☆ 4.7 Review

Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies

PHARMACEUTICS (2023)

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Article Pharmacology & Pharmacy

Water-soluble chitosan eases development of mucoadhesive buccal films and wafers for children

Karin Korelc et al.

Summary: Oromucosal films and wafers are convenient solid dosage forms for drug delivery. In this study, prednisolone containing chitosan-based mucoadhesive films and wafers were developed with different chitosan types. The mucoadhesive properties, drug release rate, and permeability of the formulations were evaluated. The results showed that chitosan type, solvent, and preparation method influenced the mucoadhesive properties, drug release rate, and permeability. The mucoadhesive wafers with a slower drug release rate and stronger mucoadhesion were considered promising alternatives to films.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2023)

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Review Chemistry, Multidisciplinary

Pluronic® triblock copolymer-based nanoformulations for cancer therapy: A 10-year overview

Karine Cappuccio de Castro et al.

Summary: This paper reviews the literature on the use of Pluronic (R) triblock copolymers for drug encapsulation in the past 10 years. It focuses on the progress of drug delivery systems (e.g. micelles, liposomes, micro/nanoemulsions, hydrogels and nanogels, polymersomes and niosomes) and discusses the benefits of Pluronic (R) triblock copolymers as biological response modifiers and pharmaceutical additives, adjuvants, and stabilizers. The paper also highlights the advantages and limitations of developing site-specific targeting approaches based on Pluronic-based nanostructures in cancer treatment, as well as innovative examples for improving tumor cytotoxicity while reducing side effects.

JOURNAL OF CONTROLLED RELEASE (2023)

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Editorial Material Biotechnology & Applied Microbiology

RNA and nanocarriers: next generation drug and delivery platform take center stage

Jessica Rouge

Summary: The rapid deployment of mRNA vaccines against COVID-19 is possible due to early studies on RNA nanocarriers, specifically the study by Zimmermann et al. that demonstrated the efficacy of RNA nanocarriers in vivo. This study, along with others, eventually led to the development of Onpattro, the first FDA-approved RNA formulation.

TRENDS IN BIOTECHNOLOGY (2023)

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Article Polymer Science

Antibacterial and cytotoxicity assessment of poly (N-vinyl imidazole)/nitrogen-doped graphene quantum dot nanocomposite hydrogels

Solmaz Massoudi et al.

Summary: Two series of pH-sensitive poly (N-vinyl imidazole)/nitrogen-doped graphene quantum dots nanocomposite hydrogels (PVI/NGQD) were successfully synthesized via in situ polymerization method. The swelling behavior of the hydrogels was influenced by the crosslinker and NGQD content, and the incorporation of NGQDs increased the crystallinity and thermal stability of the nanocomposites. The nanocomposite hydrogels exhibited antibacterial activity and potential for biomedical applications.

POLYMER BULLETIN (2023)

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Review Chemistry, Medicinal

Lactoferrin as a Component of Pharmaceutical Preparations: An Experimental Focus

Fabiola Guzman-Mejia et al.

Summary: Lactoferrin is a versatile glycoprotein with potential therapeutic applications in the pharmaceutical field. It can be used as a bioactive component or carrier in various formulations such as nanoparticles and liposomes. Lactoferrin has shown promise in enhancing the activity of antibiotics and protecting drugs from degradation in the intestine. It can also be used as a delivery system for drugs that cannot cross the blood-brain barrier. This manuscript focuses on the therapeutic possibilities of lactoferrin-containing pharmaceutical preparations and its interactions with tissue receptors, with the aim of improving drug bioavailability and reducing antimicrobial resistance.

PHARMACEUTICALS (2023)

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Article Allergy

Evaluation of pediatric patients with suspected polyethylene glycol and polysorbate allergy before mRNA SARS-CoV2 vaccination

Betul Gemici Karaaslan et al.

Summary: This study aimed to evaluate the role of PEG sensitivity in vaccination decision-making for pediatric patients with allergic reactions to the SARS-CoV2 vaccine. Seventeen patients had a reduced readiness to receive the COVID-19 vaccine after developing hypersensitivity to multiple drugs. Skin testing and basophil activation tests were conducted, and while most patients with negative results received the vaccine without complications, some patients experienced recurrence despite negative tests.

ALLERGOLOGIA ET IMMUNOPATHOLOGIA (2023)

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Review Pharmacology & Pharmacy

A pipeline analysis of advanced therapy medicinal products

Georgina C. Wilkins et al.

Summary: Advanced therapy medicinal products (ATMPs) are categorized into gene, somatic cell, tissue-engineered, or combined therapies. A total of 12 ATMPs are marketed in the EU and UK, out of which 4 are identified within 482 unique ATMPs in 583 clinical trials. Gene therapies accounted for 57.1% of the total records, while combined therapies accounted for only 1.6%. Various indications were covered, including 130 haematological malignancies and 60 genetic disorders. Marketing authorisation intelligence was included in 14% of the records.

DRUG DISCOVERY TODAY (2023)

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Letter Pediatrics

I-ACT for Children: helping close the gap in drug approval for adults and children

Max J. Coppes et al.

PEDIATRIC RESEARCH (2023)

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Letter Allergy

Safety of mRNA vaccination for COVID-19 in children with polyethylene glycol (PEG)-asparaginase allergy

Rebecca Doyle et al.

PEDIATRIC ALLERGY AND IMMUNOLOGY (2023)

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Review Polymer Science

Chitosan-Based Polymer Blends for Drug Delivery Systems

Malkiet Kaur et al.

Summary: Polymers, particularly polymer blends, are extensively used for developing drug delivery systems that provide controlled release of therapeutic agents. This review focuses on the utilization of chitosan blends in enhancing its properties and discusses various applications in drug delivery. Nanocarriers using chitosan blends have shown to be cost-effective, efficient, and prolonged release carriers that can be incorporated into suitable dosage forms.

POLYMERS (2023)

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Article Pharmacology & Pharmacy

Design, Evaluation and Comparison of Nanostructured Lipid Carriers and Chitosan Nanoparticles as Carriers of Poorly Soluble Drugs to Develop Oral Liquid Formulations Suitable for Pediatric Use

Giulia Nerli et al.

Summary: There is a need for pediatric drug formulations to avoid safety and quality risks associated with the use of adult dosage forms. In this study, chitosan nanoparticles (CSNPs) and nanostructured lipid carriers (NLCs) were developed as potential nanocarriers for oral pediatric solutions of cefixime. The CSNPs showed better stability and drug release profiles compared to NLCs, making them a promising option for pediatric drug delivery.

PHARMACEUTICS (2023)

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Review Pharmacology & Pharmacy

Exploring the Potential of Nanotechnology in Pediatric Healthcare: Advances, Challenges, and Future Directions

Hossein Omidian et al.

Summary: The utilization of nanotechnology in pediatric medicine has led to significant advancements in drug delivery, disease diagnosis, and tissue engineering. Nanotechnology allows for the manipulation of materials at the nanoscale, resulting in improved drug effectiveness and reduced toxicity. Various nanosystems, such as nanoparticles, nanocapsules, and nanotubes, show promise in treating pediatric diseases and overcoming treatment obstacles. However, it is important to acknowledge the inherent risks and limitations associated with the use of nanoparticles. This review provides a comprehensive summary of the current literature on nanotechnology in pediatric medicine, highlighting its potential to revolutionize pediatric healthcare while addressing challenges and limitations.

PHARMACEUTICS (2023)

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Review Pharmacology & Pharmacy

Approved Nanomedicine against Diseases

Yuanchao Jia et al.

Summary: Nanomedicine is a branch of medicine that uses nanotechnology for disease prevention and treatment. It has revolutionized medicine by improving drug efficacy, reducing toxicity, and targeting drug delivery. Nanomedicine has shown significant potential in treating major diseases like cancer, infections, and cardiovascular diseases. Although clinical implementation is still limited, the use of nanoscale drugs is increasingly being explored to minimize side effects and improve therapeutic outcomes.

PHARMACEUTICS (2023)

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Review Pharmacology & Pharmacy

Chitosan: A Potential Biopolymer in Drug Delivery and Biomedical Applications

Nimeet Desai et al.

Summary: Chitosan, derived from chitin, is a promising material for drug delivery and biomedical applications. Different extraction techniques can produce chitosan with unique properties, which can be further modified to enhance bioactivities. Chitosan-based drug delivery systems have been developed for various administration routes, allowing for targeted and sustained release of drugs. It has also been used in biomedical applications such as tissue regeneration and gene delivery. Modified chitosan derivatives offer innovative materials with potential in biomedical applications. This article summarizes recent findings on chitosan and its applications in drug delivery and biomedical science.

PHARMACEUTICS (2023)

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Article Pharmacology & Pharmacy

Patient-centric drug product development: Acceptability across patient populations-Science and evidence

Sven Stegemann et al.

Summary: The 6th APV Winter Conference, organized by the APV PaCeMe IN Task Force, was held in Salzburg, Austria from January 19-20, 2023. The conference was dedicated to advancing patient-centric drug development, considering emerging evidence and increasing regulatory requirements.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2023)

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Review Pediatrics

Regenerative medicine: current research and perspective in pediatric surgery

Koichi Deguchi et al.

Summary: The field of regenerative medicine is advancing with research on cell manipulation technologies, gene therapy, and new materials. Recent progress in preclinical and clinical studies may bring regenerative medicine from laboratory research to clinical reality. However, constructing bioengineered transplantable organs still faces challenges such as engineering elaborate tissues and adjusting host environmental factors.

PEDIATRIC SURGERY INTERNATIONAL (2023)

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Review Biochemistry & Molecular Biology

Synthetic biology-inspired cell engineering in diagnosis, treatment, and drug development

Ninglin Zhao et al.

Summary: Synthetic biology provides genetic tools to reprogram and engineer cells for improved performance and diverse applications in biomedicine. However, applying genetically engineered cells in clinical practice faces limitations and challenges. This literature review updates the recent advances in biomedical applications of cell engineering, including diagnosis, treatment, and drug development, and discusses future directions to optimize therapeutic activities in specific diseases.

SIGNAL TRANSDUCTION AND TARGETED THERAPY (2023)

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Review Biochemistry & Molecular Biology

CRISPR/Cas9 therapeutics: progress and prospects

Tianxiang Li et al.

Summary: CRISPR/Cas9 gene-editing technology is an ideal tool for treating diseases by repairing mutations or disrupting disease-causing genes. However, effectively delivering the CRISPR system to diseased cells in vivo is currently lacking, and nonviral vectors with target recognition functions may be the focus of future research. Pathological and physiological changes resulting from disease onset can be used for targeted delivery or gene editing.

SIGNAL TRANSDUCTION AND TARGETED THERAPY (2023)

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Review Pharmacology & Pharmacy

Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines

Erik Wollmer et al.

Summary: Despite progress in paediatric drug development, there is a need for better medications for children. This review provides comprehensive data on the ontogeny of gastrointestinal conditions in children, emphasizing the importance of addressing existing data gaps and conducting further research.

ADVANCED DRUG DELIVERY REVIEWS (2022)

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Review Chemistry, Applied

Analysis of clinical trials on biomaterial and therapeutic applications of chitosan: A review

Maithili N. Kantak et al.

Summary: Chitosan, a modified natural carbohydrate polymer, has a wide range of medical and pharmaceutical applications. It can be used as a biomaterial in medical devices and as an excipient, drug carrier, or therapeutic agent in pharmaceuticals. Numerous clinical studies are being conducted to investigate the safety and efficacy of chitosan and its biomaterials/nanoparticles.

CARBOHYDRATE POLYMERS (2022)

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Article Pharmacology & Pharmacy

Osteosarcoma from the unknown to the use of exosomes as a versatile and dynamic therapeutic approach

Ana Santos et al.

Summary: Osteosarcoma (OS) is the most common primary malignant tumor of bone in children. Nanotechnology has developed exosomes as drug delivery systems that can release drugs directly at the tumor cells and reduce their toxicity.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2022)

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Review Biotechnology & Applied Microbiology

New challenges in the use of nanomedicine in cancer therapy

Mahmood Rasool et al.

Summary: Nanomedicines have been applied as alternative treatments for anticancer agents, utilizing their small size to achieve specific site targeting and reduce toxic side effects. They also offer cost savings by requiring minute amounts of drugs. Nanotechnology has been effectively utilized in the preparation of these drugs, and large nanomaterials have been used to develop novel cancer cures.

BIOENGINEERED (2022)

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Review Immunology

Adoptive Cell Therapy in Pediatric and Young Adult Solid Tumors: Current Status and Future Directions

John A. Ligon et al.

Summary: This review discusses novel adoptive cellular therapies for solid tumors in children and young adults, including T-cell, NK-cell, and myeloid cell-based therapies. While these approaches have shown promise, challenges such as poor trafficking to the tumor and immunosuppressive mechanisms in the tumor microenvironment remain. The review also explores new strategies proposed to address these challenges and ongoing clinical trials.

FRONTIERS IN IMMUNOLOGY (2022)

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Article Biochemistry & Molecular Biology

A Stepwise Framework for the Systematic Development of Lipid Nanoparticles

Joao Basso et al.

Summary: This article presents a stepwise framework for nanoparticle production for disulfiram delivery. It involves analysis of drug in lipid solubility to select suitable liquid lipids, drug partitioning studies to determine solid lipids with increased capacity for solubilizing and entrapping disulfiram, and microscopic evaluation of physical compatibility between liquid and solid lipids to indicate promising core compositions. The impact of the outer surfactant layer on the colloidal properties of the nanosystems is evaluated using machine learning algorithms.

BIOMOLECULES (2022)

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Article Medicine, General & Internal

Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

Maja Pizevska et al.

Summary: Advanced Therapy Medicinal Products (ATMPs) such as cell, gene, and tissue-engineered therapies offer significant therapeutic benefits. However, managing their development within existing regulatory frameworks is complex. Legislation and regulation for ATMPs should prioritize patient safety while promoting innovation and optimizing the development of these novel therapies. Ongoing dynamic dialogue between stakeholders and regulatory science is crucial to facilitate the establishment of practical ATMP regulatory guidelines.

FRONTIERS IN MEDICINE (2022)

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Article Medicine, General & Internal

Nanoparticles for Diagnosis and Target Therapy in Pediatric Brain Cancers

Clara Guido et al.

Summary: Pediatric brain tumors require urgent novel diagnostic and therapeutic solutions. Nanoparticles, with their ability to cross the blood-brain barrier, are being increasingly investigated as precision nanomedicine tools for the diagnosis and therapy of pediatric brain cancers.

DIAGNOSTICS (2022)

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Article Pharmacology & Pharmacy

Innovative, Sugar-Free Oral Hydrogel as a Co-administrative Vehicle for Pediatrics: a Strategy to Enhance Patient Compliance

Margarida Pereira et al.

Summary: Palatability and swallowability are challenges in administering medication orally to pediatric patients. This paper reports the development of a new hydrogel vehicle that is adapted for pediatric use. The formulations were studied for properties such as taste, rheology, mucoadhesion, efficacy, and stability. Several final formulations were selected and found to have no interactions with medications. These sugar-free hydrogel vehicles are designed to provide a more pleasant and safer experience for pediatric patients taking solid dosage forms.

AAPS PHARMSCITECH (2022)

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Review Oncology

ACCELERATE-Five years accelerating cancer drug development for children and adolescents

Andrew D. J. Pearson et al.

Summary: Rapid evaluation and regulatory approval of new drugs are crucial for improving survival and reducing side-effects for children and adolescents with cancer. ACCELERATE organization facilitates communication and collaboration among academia, industry, patient advocates, and regulators to prioritize drug development and promote a patient-centric approach.

EUROPEAN JOURNAL OF CANCER (2022)

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Article Pharmacology & Pharmacy

Paediatric specific dosage forms: Patient and formulation considerations

Dilawar Khan et al.

Summary: This article discusses the factors affecting the safety, toxicity, and efficacy of pediatric drug delivery systems, as well as the anatomical and physiological differences between children and adults. It evaluates the advantages, limitations, and acceptability of current pediatric dosage forms, and explores techniques to overcome barriers associated with non-adherence to pediatric medications.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2022)

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Article Pediatrics

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Athimalaipet Ramanan et al.

Summary: The COVID-19 pandemic has stimulated new approaches in pediatric clinical research, which Conect4children recommends retaining for future use to improve efficiency, reduce costs, and promote research equity.

PEDIATRIC RESEARCH (2022)

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Review Biotechnology & Applied Microbiology

Engineering the next generation of cell-based therapeutics

Caleb J. Bashor et al.

Summary: The widespread clinical translation and commercialization of cell-based therapies are hindered by challenges related to cell source, product quality, and manufacturing processes. However, biological engineering approaches such as genome editing, synthetic biology, and the use of biomaterials are gradually addressing these issues.

NATURE REVIEWS DRUG DISCOVERY (2022)

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Article Substance Abuse

Understanding caregiver acceptance of screening for family substance use in pediatric clinics serving economically disadvantaged children

Pamela A. Matson et al.

Summary: This study examined caregiver acceptance of pediatricians screening for family/household substance use during well-child visits, finding that the majority of caregivers consider this screening to be appropriate. Substance use in the family/household was reported by over half of caregivers, with cigarettes being the most common substance. Caregivers with concerns about substance use in their family/household were less likely to trust their pediatrician.

SUBSTANCE ABUSE (2022)

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Review Pharmacology & Pharmacy

Nanotechnology-Based Diagnostic and Therapeutic Strategies for Neuroblastoma

Hui Yan et al.

Summary: Neuroblastoma (NB), as the most common extracranial solid tumor in childhood, poses a significant threat to children's health. The current diagnostic and therapeutic approaches for NB are inadequate due to the heterogeneity and invisibility of NB tumors. Nanomedicine, with its excellent physiological and chemical properties, has gained widespread attention in oncology research. This review comprehensively summarizes the advancements in nanotechnology-based multimodal synergistic diagnosis and treatment of NB and discusses the challenges related to biocompatibility and toxicity of nanomedicine.

FRONTIERS IN PHARMACOLOGY (2022)

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Review Medicine, General & Internal

Development of CAR T Cell Therapy in Children-A Comprehensive Overview

Michael Boettcher et al.

Summary: CAR-T cell therapy has revolutionized the treatment of relapsed and refractory leukemia and lymphoma in pediatric and young adult patients. Efforts should be made to develop CAR therapeutics and introduce new technologies to address the urgent need for more potent and specific therapies in childhood malignancies. This article discusses the basic aspects, evolution, and drawbacks of childhood CAR-T cell therapy, along with the latest clinically relevant information.

JOURNAL OF CLINICAL MEDICINE (2022)

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Review Pharmacology & Pharmacy

Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies

Carsten W. Lederer et al.

Summary: Advanced therapy medicinal products show great promise in pediatric applications, with potential to improve treatment outcomes for untreatable disorders and inherited diseases. Early application in children may provide better results and reduce overall requirements.

PHARMACEUTICS (2022)

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Article Engineering, Biomedical

Controlled temperature-mediated curcumin release from magneto-thermal nanocarriers to kill bone tumors

A. Khodaei et al.

Summary: A magneto-thermal nanocarrier that can control the release of curcumin was developed, and its combination with hyperthermia showed synergistic effects in killing osteosarcoma cells.

BIOACTIVE MATERIALS (2022)

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Review Pediatrics

Formulation Challenges and Strategies to Develop Pediatric Dosage Forms

Wedad A. Malkawi et al.

Summary: The development of pediatric-specific dose forms is challenging due to clinical and physiological factors. Oral and buccal dosage forms are commonly used for pediatric patients, with relevant legislation encouraging and regulating research. However, there is a need for further development of pediatric-specific formulations.

CHILDREN-BASEL (2022)

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Review Biochemistry & Molecular Biology

Pharmacomicrobiomics in Pediatric Oncology: The Complex Interplay between Commonly Used Drugs and Gut Microbiome

Davide Leardini et al.

Summary: The gut microbiome plays a crucial role in pediatric oncology, influencing disease progression, treatment effectiveness, and clinical outcomes. Treatment courses for pediatric cancer often lead to changes in the gut microbiome due to modifications in diet and the use of various drugs. Understanding the role of the pharmacomicrobiome in pediatric oncology is important for optimizing treatment strategies.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2022)

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Review Chemistry, Multidisciplinary

Where Is Nano Today and Where Is It Headed? A Review of Nanomedicine and the Dilemma of Nanotoxicology

Catia Domingues et al.

Summary: Worldwide development and application of nanotechnology have led to significant scientific advancements. It is important to balance the high expectations and concerns associated with this field. Nanomedicine, a specific arm of nanotechnology, focuses on the diagnosis, treatment, and monitoring of various diseases. However, the concept of nanotoxicology has also emerged as a crucial aspect of nanomedicine. More research is needed to identify potential adverse effects and ensure the safety of nanomedicines.

ACS NANO (2022)

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Article Multidisciplinary Sciences

Administration of oral dosage forms of medicines to children in a resource limited setting

Abarna Nadeshkumar et al.

Summary: This study describes the administration practice by parents when giving oral dosage forms of medications to children. The findings indicate that there are several challenges and issues, such as inappropriate dosage forms, safety concerns with dissolving medications in water, and the use of inappropriate measuring devices.

PLOS ONE (2022)

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Article Pharmacology & Pharmacy

Lipid nanoparticles in the development of mRNA vaccines for COVID-19

Barnabas Wilson et al.

Summary: COVID-19 pandemic has caused severe crisis globally, and LNPs may play a crucial role in vaccine development and delivery.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2022)

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Article Cell & Tissue Engineering

Clinical trials of stem cell-based therapies for pediatric diseases: a comprehensive analysis of trials registered on ClinicalTrials.gov and the ICTRP portal site

Yinwen Ji et al.

Summary: This study provides a comprehensive picture of the utilization of stem cells for the treatment and management of childhood diseases. However, there is a lack of quantity and quality in clinical trials in this area, and there is an urgent need for larger and better-designed trials. Additionally, it is important to optimize the management of the registration platform and shorten the time it takes for research results to be published.

STEM CELL RESEARCH & THERAPY (2022)

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Article Pharmacology & Pharmacy

Recommendations on Off-Label Drug Use in Pediatric Guidelines

Min Meng et al.

Summary: This study systematically analyzed the supporting evidence, drug information, and type of off-label drug use in pediatric guidelines, finding gaps in reporting and evidence of off-label drug use recommendations that could expose children to medical risks.

FRONTIERS IN PHARMACOLOGY (2022)

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Review Immunology

The Past, Present, and Future of Non-Viral CAR T Cells

Alex Moretti et al.

Summary: Adoptive transfer of chimeric antigen receptor (CAR) T lymphocytes is a powerful immunotherapy technique. However, the accessibility to viral vectors for T cell transfection hampers the widespread use of cell therapy. Non-viral vectors offer a more versatile, flexible, and sustainable alternative for next-generation CAR T cell manufacturing.

FRONTIERS IN IMMUNOLOGY (2022)

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Review Pharmacology & Pharmacy

New Advances in Biomedical Application of Polymeric Micelles

Ana Figueiras et al.

Summary: Nanomedicine, specifically the study of polymeric micelles (PMs), has emerged as a significant area of medicine in the last decade. PMs are colloidal dispersions of amphiphilic compounds that assemble into a core-shell structure, with a hydrophobic core and a hydrophilic shell. They improve the solubility and stability of drugs and can be absorbed and transported to the therapeutic target. PMs have high load capacity and are synthesized using a reproducible and cost-effective method. pH and temperature are commonly studied stimuli for enhanced drug release.

PHARMACEUTICS (2022)

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Review Biochemistry & Molecular Biology

Recent Advances of Chitosan Formulations in Biomedical Applications

Mohammed A. S. Abourehab et al.

Summary: Chitosan, a naturally abundant cationic polymer, offers attractive characteristics such as renewability, hydrophilicity, biodegradability, biocompatibility, and antimicrobial activity. It has a wide range of applications in drug delivery, protective coatings, food packaging, and wastewater treatment. The structure of chitosan allows for various reactions and electrochemical interactions, improving its physicochemical properties. This review article discusses the extensive research on chitosan-based composites for drug, gene, protein, and vaccine delivery applications, as well as its applications in tissue engineering and wound healing. The challenges and future perspectives for chitosan in biomedical applications are also addressed.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2022)

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Review Pharmacology & Pharmacy

Nanotechnology for the treatment of paediatric diseases: A review

Morgana Souza Marques et al.

Summary: In recent years, there has been a growing interest in the development of paediatric formulations, and nanotechnology has been proposed as a beneficial tool. This review explored the literature on various types of nanostructures for treating paediatric diseases and found that nanotechnology has the potential to enhance therapeutic efficacy, improve drug taste, and enable targeted therapy. The most commonly studied nanostructures were polymeric nanoparticles, lipid-based nanocarriers, and polymeric micelles. Specific tests designed for paediatric formulations included efficacy and safety studies in animal models of paediatric diseases, as well as palatability verification.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2022)

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Article Multidisciplinary Sciences

Potential solutions for manufacture of CAR T cells in cancer immunotherapy

Ulrich Blache et al.

Summary: CAR T cell therapy is effective in treating cancer, but obstacles in biology and manufacturing hinder its widespread application. New technologies are needed to enable the treatment of larger patient groups.

NATURE COMMUNICATIONS (2022)

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Review Nutrition & Dietetics

Tackling Dyslipidemia in Obesity from a Nanotechnology Perspective

Laura M. Trandafir et al.

Summary: Obesity and dyslipidemia are key features of metabolic syndrome, and conventional drugs for these disorders have limitations. Targeted nanotherapy emerges as a revolutionary technology with advantages such as specific cell targeting, drug protection, and sustained drug release.

NUTRIENTS (2022)

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Review Pharmacology & Pharmacy

Lactoferrin-Conjugated Nanoparticles as New Antivirals

Malgorzata Krzyzowska et al.

Summary: Lactoferrin is an iron-binding glycoprotein with multiple functions, including antiviral activity and modulation of immune responses. Nanotechnology has recently gained attention for its potential use in developing new antiviral drugs.

PHARMACEUTICS (2022)

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Article Chemistry, Physical

Hyperbranched-star PEI-g-PEG as a nonviral vector with efficient uptake and hypotoxicity for retinoblastoma gene therapy application

Jiahao Wang et al.

Summary: In this study, PEI-g-PEG was used as a gene carrier to prepare nonviral vectors with efficient uptake and low toxicity for retinoblastoma gene therapy. The results showed that PEGylation could significantly reduce the cytotoxicity of the vectors and improve gene transfection efficiency.

COLLOID AND INTERFACE SCIENCE COMMUNICATIONS (2022)

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Review Biochemistry & Molecular Biology

Lipid Nanoparticles as Delivery Vehicles for Inhaled Therapeutics

Ellenmae W. X. Leong et al.

Summary: Lipid nanoparticles (LNPs) have emerged as a powerful non-viral carrier for drug delivery. Current investigations are focusing on applying LNPs to deliver inhaled therapeutics directly to the lungs, particularly in respiratory diseases. This review evaluates the advantages and challenges of pulmonary drug delivery system and provides a perspective on the future prospects of LNP-mediated delivery of inhaled therapeutics for respiratory diseases.

BIOMEDICINES (2022)

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Article Chemistry, Medicinal

Overcoming Challenges in Pediatric Formulation with a Patient-Centric Design Approach: A Proof-of-Concept Study on the Design of an Oral Solution of a Bitter Drug

John Dike N. Ogbonna et al.

Summary: Designing oral formulations for children is challenging, especially considering their preferences and characteristics. This study developed an oral solution for a bitter drug (ranitidine) by using a patient-centric design process and assessed its stability and quality. The results demonstrated the importance of in-use stability protocols in the evaluation of pediatric formulations.

PHARMACEUTICALS (2022)

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Review Chemistry, Medicinal

Nanotechnology for Pediatric Retinoblastoma Therapy

Eleonora Russo et al.

Summary: This article reviews the current use and advances of nanomedicine in the treatment of retinoblastoma, with a focus on the development of nanodelivery systems. These systems provide sustained drug release and help overcome the side-effects of traditional chemotherapy.

PHARMACEUTICALS (2022)

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Article Pharmacology & Pharmacy

Administration of medicines to children: a practical guide

Lucinda Smith et al.

Summary: When giving medicines to children, it's important to consider factors such as age, swallowing ability, and accessibility. Altering the taste and mouth feel of medicines can help improve their palatability. Pharmacists or medicines information services can provide advice on suitable formulations or methods of administration.

AUSTRALIAN PRESCRIBER (2022)

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Review Toxicology

Safety and Toxicity Implications of Multifunctional Drug Delivery Nanocarriers on Reproductive Systems In Vitro and In Vivo

Anas Ahmad

Summary: In recent years, nanotechnological advancements have shown various applications in different fields, such as bio-imaging, drug delivery, and nanomedicine. However, concerns about human exposure to nanomaterials and their impact on health may limit their wider use. This review summarizes the safety and toxicological outcomes of nanoparticles on the reproductive system, including their interaction with the placenta and potential fetal abnormalities. Regulatory requirements and guidelines for testing the safety and toxicity of nanoparticles in the reproductive system are also discussed.

FRONTIERS IN TOXICOLOGY (2022)

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Review Medicine, Research & Experimental

Pediatric Pharmacokinetics and Dose Predictions: A Report of a Satellite Meeting to the 10th Juvenile Toxicity Symposium

Bianca D. van Groen et al.

Summary: In the field of pediatric drug development, understanding differences in pharmacokinetics is crucial. Apart from PBPK models, simpler methods like allometry and maturation functions also perform well. Combining knowledge from different methods and information sources can help validate models, though further research is still needed.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2021)

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Article Pharmacology & Pharmacy

A best practice framework for applying physiologically-based pharmacokinetic modeling to pediatric drug development

Trevor N. Johnson et al.

Summary: Pediatric physiologically-based pharmacokinetic (PBPK) models have broad applications in drug development, being used to project doses and replace clinical studies. Despite this, full integration of PBPK models in regulatory submissions is still lacking. Emerging data supports the expanded integration of PBPK models in pediatric regulatory guidance, presenting best practice standards for further development through interaction among regulators, industry, and model providers.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2021)

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Review Pharmacology & Pharmacy

Nanomedicine to fight infectious disease

Kathryn M. Rubey et al.

Summary: The ubiquity and potency of antibiotics may give a false impression that infection is a solved problem. However, bacterial infections remain a major cause of illness and death. The use of systemic antibiotics can lead to destruction of the gut microbiome and increase the risk of infections, while the rise of multi-drug resistant microorganisms poses a growing threat to treatment.

ADVANCED DRUG DELIVERY REVIEWS (2021)

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Article Pediatrics

Adherence to treatment in paediatric patients - results of the nationwide survey in Poland

Przemyslaw Kardas et al.

Summary: Physicians caring for Polish pediatric patients underestimate the prevalence of medication non-adherence and believe it is a problem of other doctors. This optimistic bias is particularly pronounced in older doctors. These results highlight important barriers to improving patient adherence that should be addressed in the education of Polish physicians.

BMC PEDIATRICS (2021)

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Meeting Abstract Hematology

A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia

Bijal D. Shah et al.

BLOOD (2021)

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Article Pharmacology & Pharmacy

Best practices for selection of excipients for paediatrics-Workshop reflection

Smita Salunke et al.

Summary: The development of age-appropriate formulations for the paediatric population is a key focus for the pharmaceutical industry, impacting excipient use. Selecting excipients with appropriate safety and tolerability is a major challenge in paediatric formulation development, influenced by factors such as target age group, route of administration, and dosage form. Scientists are encouraged to assess the suitability of excipients to the specific paediatric population using the principle of benefit to risk balance.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2021)

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Review Biochemistry & Molecular Biology

Potential implications of DMET ontogeny on the disposition of commonly prescribed drugs in neonatal and pediatric intensive care units

Siavosh Naji-Talakar et al.

Summary: Pediatric patients, especially neonates and infants, are more susceptible to adverse drug events, and it is important to adjust doses accordingly. The differences in drug metabolism and excretion mechanisms between children and adults, as well as the importance of considering developmental stages, are discussed. Ontogeny-informed PBPK modeling provides a better alternative to predict the pharmacokinetics of drugs in children.

EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY (2021)

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Review Chemistry, Medicinal

Paediatric Medicines - Regulatory Drivers, Restraints, Opportunities and Challenges

Isa Vieira et al.

Summary: Investment in pharmaceutical development for pediatric use lags behind that for the adult population, with regulations requiring pediatric trials and age-appropriate drug formulations to improve quality and safety. FDA and EMA have implemented policies to foster closer collaboration and provide financial incentives for the pharmaceutical industry to address this asymmetry.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Review Biotechnology & Applied Microbiology

Engineering precision nanoparticles for drug delivery

Michael J. Mitchell et al.

Summary: The development of nanoparticles has shown promising clinical applications, overcoming the limitations of therapeutic interventions and biological barriers. Precision therapies have enhanced treatment efficacy through personalized interventions. Advancements in nanoparticle design aim to optimize drug delivery, improving efficacy in general applications and enabling tailored designs for precision applications.

NATURE REVIEWS DRUG DISCOVERY (2021)

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Article Medicine, General & Internal

CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β-Thalassemia

H. Frangoul et al.

Summary: Research utilizing CRISPR-Cas9 technology for gene editing in patients with TDT and SCD showed high levels of edited alleles in bone marrow and blood, leading to partial or complete elimination of symptoms.

NEW ENGLAND JOURNAL OF MEDICINE (2021)

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Article Biochemistry & Molecular Biology

Targeted dendrimers for antagonizing the migration and viability of NALM-6 lymphoblastic leukemia cells

Chuda Chittasupho et al.

Summary: The study constructed a CXCR4-targeted PAMAM dendrimer that selectively targeted leukemic precursor B cells and inhibited cell migration. These findings may contribute to the discovery of potential anti-metastatic drugs for lymphoblastic leukemia.

BIOORGANIC CHEMISTRY (2021)

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Article Chemistry, Applied

pH-sensitive chitosan nanoparticles loaded with dolutegravir as milk and food admixture for paediatric anti-HIV therapy

K. Priya Dharshini et al.

Summary: The study aimed to develop Chitosan-based polymeric nanoparticles of anti-HIV drug Dolutegravir, which showed improved therapeutic efficiency and lesser cytotoxicity compared to the pure drug in treating HIV-infected T-lymphatic cell lines. The use of Chitosan from a novel source for drug delivery carrier has opened exceptional prospects for delivering drugs efficiently to paediatrics.

CARBOHYDRATE POLYMERS (2021)

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Review Biochemistry & Molecular Biology

Controlled Drug Delivery Systems: Current Status and Future Directions

Shivakalyani Adepu et al.

Summary: The paper discusses the evolution of drug delivery systems, the limitations of conventional drug delivery, and the details of controlled drug delivery systems, including design considerations, classifications, and recent research findings on nano-drug delivery, targeted drug delivery, and smart drug delivery using intelligent biomaterials. The challenges and future directions in controlled drug delivery are also addressed in the conclusion.

MOLECULES (2021)

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Editorial Material Nanoscience & Nanotechnology

The role and impact of polyethylene glycol on anaphylactic reactions to COVID-19 nano-vaccines

P. Bigini et al.

Summary: Recent studies have suggested that polyethylene glycol may be a possible cause of anaphylactic reactions to COVID-19 vaccines, but evidence supporting this is contradictory and other factors may be involved.

NATURE NANOTECHNOLOGY (2021)

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Article Pediatrics

The Pediatric Workforce: Recent Data Trends, Questions, and Challenges for the Future

Robert J. Vinci

Summary: The future of the pediatric workforce is facing challenges such as increased number of unfilled positions and low applicant numbers for pediatric specialties. To address these issues, there is a need for careful analysis and thoughtful research on pediatric workforce data, as well as comprehensive strategic planning for the future.

PEDIATRICS (2021)

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Article Pharmacology & Pharmacy

Polycaprolactone Nanoparticles as Promising Candidates for Nanocarriers in Novel Nanomedicines

Sylwia Lukasiewicz et al.

Summary: The investigation into the interactions between bio-polymeric nanoparticles and a mouse macrophage cell line revealed that non-pegylated PCL NPs were internalized more effectively and utilized the clathrin-mediated pathway. The synthesized NPs show promise as nanocarriers for therapeutic compounds.

PHARMACEUTICS (2021)

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Review Pharmacology & Pharmacy

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework

Marina Lopez-Paniagua et al.

Summary: ATMPs are innovative and complex biological products for human use, including cell therapy, tissue engineering, gene therapy, and combined products with medical devices. The development of ATMPs for treating eye diseases has rapidly expanded in recent years, offering novel therapeutic approaches for incurable conditions.

PHARMACEUTICS (2021)

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Review Cell & Tissue Engineering

Developing standards to support the clinical translation of stem cells

Jiani Cao et al.

Summary: Stem cells have great potential for regenerative medicine, but clinical translation remains challenging. Establishing a set of standards is crucial for supporting the clinical translation of stem cell applications.

STEM CELLS TRANSLATIONAL MEDICINE (2021)

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Article Pediatrics

Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008-2019

Yang Zhong et al.

Summary: This study found that pediatric clinical studies registered in ClinicalTrials.gov were dominated by small-scale interventional trials and exhibited significant heterogeneity in funding sources, funding sites, pediatric clinical conditions, and study characteristics. Despite the evolution of the results database over the past decade, efforts to strengthen the practice of systematic reporting must be continued.

BMC PEDIATRICS (2021)

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Letter Allergy

Polyethylene glycol (PEG) is a cause of anaphylaxis to the Pfizer/BioNTech mRNA COVID-19 vaccine

Priya Sellaturay et al.

CLINICAL AND EXPERIMENTAL ALLERGY (2021)

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Review Medicine, Research & Experimental

Current landscape of clinical development and approval of advanced therapies

Carolina Iglesias-Lopez et al.

Summary: This article discusses the current landscape of clinical development of advanced therapy medicinal products (ATMPs), the challenges involved, and efforts being made by stakeholders to drive progress in this field.

MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT (2021)

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Review Medicine, General & Internal

Cell Therapy: Types, Regulation, and Clinical Benefits

Abed El-Hakim El-Kadiry et al.

Summary: Cell therapy practices have a long history dating back to the 19th century, and continue to evolve with a focus on investigational and investment aspects. There are different types of cell therapies, including both stem cell and non-stem cell-based therapies, with varied immunophenotypic profiles and mechanisms of action. The benefits of cell therapies in regenerative medicine, immune diseases, and cancer have been reported, leading to a shift towards combined therapy approaches and highlighting the attractiveness of multicellular therapies over unicellular ones.

FRONTIERS IN MEDICINE (2021)

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Review Medicine, General & Internal

Strategies for Improving Inhalation Technique in Children: A Narrative Review

Anna Volerman et al.

Summary: Inhaled medicines are commonly used by children for respiratory conditions, and effective inhaler technique is crucial for controlling asthma. Education and technology-based interventions have shown promise in improving children's inhaler technique.

PATIENT PREFERENCE AND ADHERENCE (2021)

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Article Multidisciplinary Sciences

Chemical characterization (LC-MS-ESI), cytotoxic activity and intracellular localization of PAMAM G4 in leukemia cells

R. Flores-Mejia et al.

Summary: The study investigates the chemical structure, cytotoxicity, and antiproliferative effects of G4-PAMAM, as well as its intracellular localization in the HMC-1 and K-562 cell lines. The results show that G4-PAMAM generates multivalent mass spectrum values and exhibits antiproliferative activity in both tumor cell lines. Additionally, the dendrimers were found in the cytoplasm and nucleus of the studied tumor cells.

SCIENTIFIC REPORTS (2021)

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Article Medical Informatics

Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum

Gary J. Noel et al.

Summary: The inclusion of adolescents in adult clinical trials has been shown to be ethically justified and medically sound. This inclusion can help to speed up the availability of innovative new medicines to children while also ensuring safety and efficacy.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2021)

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Review Pharmacology & Pharmacy

Excipients in the Paediatric Population: A Review

Khadija Rouaz et al.

Summary: This theoretical study critically reviews the use of excipients in paediatric medicine, emphasizing the importance of safety checks and toxicity studies. It identifies common excipients used in pediatric formulations and explores the orally disintegrating tablets, ODT, as a promising pharmaceutical form for children.

PHARMACEUTICS (2021)

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Review Pharmacology & Pharmacy

Polymeric and Lipid Nanoparticles: Which Applications in Pediatrics?

Noelia Nieto Gonzalez et al.

Summary: There is a current lack of formulations suitable for pediatric patients for several drugs, leading to the need for new treatments in pediatric diseases. The application of nanotechnology in pediatric drug formulations has been suggested and studied, primarily focusing on pediatric cancer treatment. While nanomedicine shows promise in addressing pediatric needs, the development of new pediatric medicines based on nanoparticles is hindered by the lack of data on pharmacokinetics, safety, and efficacy.

PHARMACEUTICS (2021)

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Review Pharmacology & Pharmacy

Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects

Hui Zu et al.

Summary: Although non-viral vectors in gene therapy have low cytotoxicity and immunogenicity, they still face challenges in gene transfer efficiency, specificity, gene expression duration, and safety. Overcoming these obstacles is necessary to enhance the effectiveness of non-viral vectors in gene therapy.

AAPS JOURNAL (2021)

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Article Chemistry, Multidisciplinary

Liposomal Extravasation and Accumulation in Tumors as Studied by Fluorescence Microscopy and Imaging Depend on the Fluorescent Label

Guankui Wang et al.

Summary: The type of fluorescent label on liposomes significantly impacts their extravasation and accumulation in tumors. In animal experiments, indocarbocyanine lipids (ICLs) were found to spread and accumulate in tumor tissue more easily compared to fluorescent phospholipids (FPLs).

ACS NANO (2021)

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Review Chemistry, Multidisciplinary

Lipid Nanoparticles-From Liposomes to mRNA Vaccine Delivery, a Landscape of Research Diversity and Advancement

Rumiana Tenchov et al.

Summary: Lipid nanoparticles (LNPs) have become promising vehicles in the pharmaceutical industry for delivering various therapeutics, particularly highlighted in the COVID-19 mRNA vaccines. LNPs exhibit versatility and physical stability, allowing for targeted delivery of therapeutic drugs to specific locations within the body. Liposomes, an early version of LNPs, have already been widely applied in medical practice.

ACS NANO (2021)

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Review Biochemistry & Molecular Biology

The Use of Stem Cell-Derived Organoids in Disease Modeling: An Update

Joseph Azar et al.

Summary: Organoids, three-dimensional in vitro culturing models that mimic the structural and functional specificities of body organs, have great potential for disease modeling and clinical applications. However, challenges such as high cost, variability in efficiency, genetic stability, and clinical applications still exist in their culturing process.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2021)

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Article Pharmacology & Pharmacy

Predictive Performance of Physiology-Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small-Molecule Compounds in Children

Ibrahim Ince et al.

Summary: Physiology-based pharmacokinetic (PBPK) modeling has been used to support the development and guidance of dosing schemes in children for many years. By accounting for physiological differences, PBPK models can be translated from adults to children, demonstrating successful prediction of the pharmacokinetics of small-molecule compounds across different pediatric age groups.

JOURNAL OF CLINICAL PHARMACOLOGY (2021)

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Article Pharmacology & Pharmacy

Rufinamide-Loaded Chitosan Nanoparticles in Xyloglucan-Based Thermoresponsive In Situ Gel for Direct Nose to Brain Delivery

Avantika Dalvi et al.

Summary: In this study, Rufinamide-loaded chitosan nanoparticles were formulated and suspended in a thermoresponsive polymer-tamarind seed xyloglucan solution to create a nasal in situ gel for direct nose to brain drug delivery. The optimized nanoparticle formulation had favorable characteristics, and the in situ gelling formulation showed promising results in terms of direct transport efficiency and percentage.

FRONTIERS IN PHARMACOLOGY (2021)

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Review Medicine, General & Internal

Early-life gut microbiota and its connection to metabolic health in children: Perspective on ecological drivers and need for quantitative approach

Ching Jian et al.

Summary: The development of gut microbiota is linked to pediatric metabolic disorders, and manipulation of early gut microbiota may be a promising target for combating these disorders. However, there are still many knowledge gaps regarding the connection between gut microbiota and metabolic disorders.

EBIOMEDICINE (2021)

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Review Biotechnology & Applied Microbiology

Nanoparticles in the clinic: An update post COVID-19 vaccines

Aaron C. Anselmo et al.

Summary: Nanoparticles serve as a crucial technology in treating cancer, imaging tissues, and facilitating vaccination. The recent Emergency Use Authorization of COVID-19 lipid nanoparticle vaccines has highlighted the potential of nanoparticles as delivery vehicles in the forefront of biotechnology.

BIOENGINEERING & TRANSLATIONAL MEDICINE (2021)

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Editorial Material Medicine, General & Internal

The Scarcity of Approved Pediatric High-Risk Medical Devices

Juan C. Espinoza

JAMA NETWORK OPEN (2021)

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Article Ophthalmology

Carboplatin- and Etoposide-Loaded Lactoferrin Protein Nanoparticles for Targeting Cancer Stem Cells in Retinoblastoma In Vitro

Revu V. L. Narayana et al.

Summary: The study demonstrates that drug-loaded lactoferrin nanoparticles can enhance drug uptake, retention, and cytotoxicity on cancer stem cells (CSCs) and non-CSCs compared to their standard drugs, showing promising potential for overcoming chemoresistance in CSC population and improving targeted therapy outcomes.

INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE (2021)

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Review Infectious Diseases

Understanding Pediatric Drug Lag Time: Review of Selected Drug Package Inserts

Aviva Beleck et al.

Summary: Research indicates that conducting pediatric clinical trials does not pose a risk to adult licensure, as these trials did not identify any new adverse events or warnings.

JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY (2021)

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Review Engineering, Biomedical

Recent advances in transdermal drug delivery systems: a review

Woo Yeup Jeong et al.

Summary: Transdermal drug delivery systems (TDDS) offer a non-invasive alternative to conventional needle injections, with advantages including low rejection rate, convenience, and applicability to pharmaceuticals and cosmetics. Despite obstacles presented by skin physicochemical properties, research has made progress in overcoming these challenges to harness the high efficiency inherent to TDDS.

BIOMATERIALS RESEARCH (2021)

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Article Chemistry, Multidisciplinary

Synthesis, characterization and antimicrobial activity applications of grafted copolymer alginate-g-poly(N-vinyl imidazole)

Soliman Mehawed Abdellatif Soliman et al.

Summary: N-Vinyl imidazole was grafted onto sodium alginate through free radical polymerization to obtain a copolymer with a high percentage of poly(N-vinyl imidazole). The grafted copolymer exhibited excellent antimicrobial activity against both Gram-positive and Gram-negative bacteria, as well as fungi.

RSC ADVANCES (2021)

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Review Biotechnology & Applied Microbiology

The Promise and the Hope of Gene Therapy

Eleni Papanikolaou et al.

Summary: Gene therapy, proposed by visionary scientists over 30 years ago, has shown success in treating certain monogenic diseases. With the introduction of CAR-T cell therapies, gene therapy has expanded to treat a broader range of diseases. The integration of gene therapy into everyday clinical practice is expected to be gradual and impactful.

FRONTIERS IN GENOME EDITING (2021)

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Article Nanoscience & Nanotechnology

Poly(1-vinylimidazole) polyplexes as novel therapeutic gene carriers for lung cancer therapy

Gayathri Kandasamy et al.

BEILSTEIN JOURNAL OF NANOTECHNOLOGY (2020)

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Review Pharmacology & Pharmacy

Patient Centric Pharmaceutical Drug Product Design-The Impact on Medication Adherence

Enrica Menditto et al.

PHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

A Focus Group Study about Oral Drug Administration Practices at Hospital Wards-Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children

Maria Rautamo et al.

PHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018

Irin Tanaudommongkon et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Article Medical Informatics

How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

Thomas Severin et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2020)

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Article Pharmacology & Pharmacy

Squalenoyl-gemcitabine/edelfosine nanoassemblies: Anticancer activity in pediatric cancer cells and pharmacokinetic profile in mice

C. Rodriguez-Nogales et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2020)

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Review Chemistry, Medicinal

Pluronic-based nanovehicles: Recent advances in anticancer therapeutic applications

Ivana Jarak et al.

EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY (2020)

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Article Biochemistry & Molecular Biology

Ruthenium Dendrimers against Human Lymphoblastic Leukemia 1301 Cells

Sylwia Michlewska et al.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2020)

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Review Toxicology

Recent insights on indirect mechanisms in developmental toxicity of nanomaterials

Battuja Batbajar Dugershaw et al.

PARTICLE AND FIBRE TOXICOLOGY (2020)

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Article Pediatrics

Hyaluronic acid for the treatment of airway diseases in children: Little evidence for few indications

Maria Di Cicco et al.

PEDIATRIC PULMONOLOGY (2020)

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Article Multidisciplinary Sciences

Gap between pediatric and adult approvals of molecular targeted drugs

Satoshi Nishiwaki et al.

SCIENTIFIC REPORTS (2020)

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Review Engineering, Biomedical

Lactoferrin, a multi-functional glycoprotein: Active therapeutic, drug nanocarrier & targeting ligand

Ahmed O. Elzoghby et al.

BIOMATERIALS (2020)

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Article Pharmacology & Pharmacy

The rectal route of medicine administration for children: Let's get to the bottom of it!

Sara M. Hanning et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)

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Article Chemistry, Applied

Lactoferrin, a unique molecule with diverse therapeutical and nanotechnological applications

Sally Sabra et al.

INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES (2020)

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Article Geriatrics & Gerontology

Age and education as factors associated with medication literacy: a community pharmacy perspective

Javier Plaza-Zamora et al.

BMC GERIATRICS (2020)

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Article Pharmacology & Pharmacy

Population Pharmacokinetics and Model-Based Dosing Optimization of Teicoplanin in Pediatric Patients

Tao Zhang et al.

FRONTIERS IN PHARMACOLOGY (2020)

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Article Biochemistry & Molecular Biology

Machine learning applications in drug development

Clemence Reda et al.

COMPUTATIONAL AND STRUCTURAL BIOTECHNOLOGY JOURNAL (2020)

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Article Health Care Sciences & Services

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

Diane M. Turner-Bowker et al.

JOURNAL OF PATIENT-REPORTED OUTCOMES (2020)

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Review Pharmacology & Pharmacy

Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance

Eva Germovsek et al.

CLINICAL PHARMACOKINETICS (2019)

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Review Medicine, Research & Experimental

The Challenges of Pediatric Drug Development

Klaus Rose

CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL (2019)

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Article Pharmacology & Pharmacy

Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

Xiaomei I. Liu et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Article Cell Biology

Inactive ingredients in oral medications

Daniel Reker et al.

SCIENCE TRANSLATIONAL MEDICINE (2019)

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Review Biotechnology & Applied Microbiology

Benzalkonium Chlorides: Uses, Regulatory Status, and Microbial Resistance

Beatriz Merchel Piovesan Pereira et al.

APPLIED AND ENVIRONMENTAL MICROBIOLOGY (2019)

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Review Biotechnology & Applied Microbiology

RNAi therapeutic and its innovative biotechnological evolution

Yuhua Weng et al.

BIOTECHNOLOGY ADVANCES (2019)

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Article Chemistry, Multidisciplinary

Integrating Nanotechnology into Cancer Care

Piotr Grodzinski et al.

ACS NANO (2019)

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Article Biochemistry & Molecular Biology

Systematic optimization of cationic surface engineered mucoadhesive vesicles employing Design of Experiment (DoE): A preclinical investigation

Amit Verma et al.

INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES (2019)

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Review Biochemistry & Molecular Biology

Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine

Fiona O'Brien et al.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2019)

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Review Medicine, General & Internal

Clinical and Therapeutic Implications of Cancer Stem Cells

Michael F. Clarke

NEW ENGLAND JOURNAL OF MEDICINE (2019)

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Review Chemistry, Multidisciplinary

Current Applications of Nanoemulsions in Cancer Therapeutics

Elena Sanchez-Lopez et al.

NANOMATERIALS (2019)

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Review Medicine, Research & Experimental

EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Giulia Detela et al.

MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT (2019)

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Review Pharmacology & Pharmacy

Pharmacokinetics of nanotechnology-based formulations in pediatric populations

Venkata K. Yellepeddi et al.

ADVANCED DRUG DELIVERY REVIEWS (2019)

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Article Pharmacology & Pharmacy

Predictive Pediatric Modeling and Simulation Using Ontogeny Information

Ibrahim Ince et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Article Pharmacology & Pharmacy

Developmental Pharmacodynamics and Modeling in Pediatric Drug Development

Laurie S. Conklin et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Article Pharmacology & Pharmacy

Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

Carolina Iglesias-Lopez et al.

FRONTIERS IN PHARMACOLOGY (2019)

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Article Engineering, Biomedical

In-vitro and in-vivo difference in gene delivery by lithocholic acid-polyethyleneimine conjugate

Jianping Wang et al.

BIOMATERIALS (2019)

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Review Engineering, Biomedical

Liposomal formulations of photosensitizers

Sanjana Ghosh et al.

BIOMATERIALS (2019)

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Article Polymer Science

Biodegradable polymers and constructs: A novel approach in drug delivery

Shiv Kumar Prajapati et al.

EUROPEAN POLYMER JOURNAL (2019)

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Review Medicine, Research & Experimental

Nanotheranostic Pluronic-Like Polymeric Micelles: Shedding Light into the Dark Shadows of Tumors

Catia Domingues et al.

MOLECULAR PHARMACEUTICS (2019)

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Review Pharmacology & Pharmacy

Pediatric drug development in China: Reforms and challenges

Weijia Wu et al.

PHARMACOLOGICAL RESEARCH (2019)

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Review Medicine, Research & Experimental

Genetic engineering of hematopoiesis: current stage of clinical translation and future perspectives

Luigi Naldini

EMBO MOLECULAR MEDICINE (2019)

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Article Biochemistry & Molecular Biology

Intrabone hematopoietic stem cell gene therapy for adult and pediatric patients affected by transfusion-dependent β-thalassemia

Sarah Marktel et al.

NATURE MEDICINE (2019)

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Review Oncology

The journey to CAR T cell therapy: the pediatric and young adult experience with relapsed or refractory B-ALL

George Hucks et al.

BLOOD CANCER JOURNAL (2019)

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Review Medical Informatics

The Meanings of Pediatric Drug Development

Klaus Rose et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2019)

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Review Pediatrics

The age of paediatrics

Susan M. Sawyer et al.

LANCET CHILD & ADOLESCENT HEALTH (2019)

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Review Anesthesiology

Pharmacology related to paediatric anaesthesia

Meghna Maheshwari et al.

INDIAN JOURNAL OF ANAESTHESIA (2019)

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Article Health Care Sciences & Services

A Perspective on Microneedle-Based Drug Delivery and Diagnostics in Paediatrics

Liliana R. Pires et al.

JOURNAL OF PERSONALIZED MEDICINE (2019)

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Review Pharmacology & Pharmacy

Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review

L. P. Ainscough et al.

EUROPEAN JOURNAL OF HOSPITAL PHARMACY (2018)

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Review Pharmacology & Pharmacy

Drug-gut microbiota interactions: implications for neuropharmacology

Jacinta Walsh et al.

BRITISH JOURNAL OF PHARMACOLOGY (2018)

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Editorial Material Biochemistry & Molecular Biology

CAR-T in the clinic: drive with care

Rafael J. Yanez-Munoz et al.

GENE THERAPY (2018)

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Article Pharmacology & Pharmacy

Challenges for pulmonary delivery of high powder doses

Imco Sibum et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)

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Article Pharmacology & Pharmacy

Novel adhesive hyaluronic acid based solid dosage form for pediatric application

Flavia Laffleur

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2018)

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Review Materials Science, Biomaterials

Biodegradable dendrimers for drug delivery

Da Huang et al.

MATERIALS SCIENCE & ENGINEERING C-MATERIALS FOR BIOLOGICAL APPLICATIONS (2018)

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Article Pediatrics

The uncertain fate of the National Institutes of Health (NIH) pediatric research portfolio

Daniel P. Gitterman et al.

PEDIATRIC RESEARCH (2018)

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Review Pediatrics

Useful pharmacodynamic endpoints in children: selection, measurement, and next steps

Lauren E. Kelly et al.

PEDIATRIC RESEARCH (2018)

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Article Acoustics

Ultrasonic synthesis and characterization of poly(acrylamide)-co-poly (vinylimidazole)@MWCNTs composite for use as an electrochemical material

Won-Yong Jeon et al.

ULTRASONICS SONOCHEMISTRY (2018)

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Review Chemistry, Multidisciplinary

Nanomedicines for Pediatric Cancers

Carlos Rodriguez-Nogales et al.

ACS NANO (2018)

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Review Otorhinolaryngology

Epithelial-mesenchymal transition and microRNAs: Challenges and future perspectives in oral cancer

Catia Sofia da Costa Domingues et al.

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK (2018)

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Review Obstetrics & Gynecology

Public health applications of CRISPR: How children's health can benefit

Vivian S. Vigliotti et al.

SEMINARS IN PERINATOLOGY (2018)

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Review Pharmacology & Pharmacy

Buccal Dosage Forms: General Considerations for Pediatric Patients

Soledad Montero-Padilla et al.

AAPS PHARMSCITECH (2017)

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Review Pharmacology & Pharmacy

Paclitaxel: What has been done and the challenges remain ahead

Ezequiel Bernabeu et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2017)

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Review Chemistry, Multidisciplinary

PEG-PCL-based nanomedicines: A biodegradable drug delivery system and its application

Philip Grossen et al.

JOURNAL OF CONTROLLED RELEASE (2017)

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Article Medicine, General & Internal

Hematopoietic Stem-Cell Gene Therapy for Cerebral Adrenoleukodystrophy

Florian Eichler et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

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Article Pediatrics

Age Limit of Pediatrics

Amy Peykoff Hardin et al.

PEDIATRICS (2017)

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Review Pharmacology & Pharmacy

Liposomal Formulations in Clinical Use: An Updated Review

Upendra Bulbake et al.

PHARMACEUTICS (2017)

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Review Multidisciplinary Sciences

Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

Toon van der Gronde et al.

PLOS ONE (2017)

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Review Health Care Sciences & Services

Personalized Nanomedicine: A Revolution at the Nanoscale

Cristina Fornaguera et al.

JOURNAL OF PERSONALIZED MEDICINE (2017)

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Article Pharmacology & Pharmacy

Enhancing the Pediatric Drug Development Framework to Deliver Better Pediatric Therapies Tomorrow

Christina Bucci-Rechtweg

CLINICAL THERAPEUTICS (2017)

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Review Pharmacology & Pharmacy

Challenges Associated with Route of Administration in Neonatal Drug Delivery

Matthew W. Linakis et al.

CLINICAL PHARMACOKINETICS (2016)

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Review Pediatrics

Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects

Diana A. van Riet-Nales et al.

ARCHIVES OF DISEASE IN CHILDHOOD (2016)

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Article Pharmacology & Pharmacy

Oral drug dosage forms administered to hospitalized children: Analysis of 117,665 oral administrations in a French paediatric hospital over a 1-year period.

A. Lajoinie et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2016)

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Article Chemistry, Multidisciplinary

Development and in vivo evaluation of child-friendly lopinavir/ritonavir pediatric granules utilizing novel in situ self-assembly nanoparticles

Kevin Pham et al.

JOURNAL OF CONTROLLED RELEASE (2016)

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Article Medicine, General & Internal

Lentiviral haemopoietic stem-cell gene therapy in early-onset metachromatic leukodystrophy: an ad-hoc analysis of a non-randomised, open-label, phase 1/2 trial

Mario Sessa et al.

LANCET (2016)

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Article Chemistry, Analytical

Poly(amidoamine) (PAMAM): An emerging material for electrochemical bio(sensing) applications

Elif Burcu Bahadir et al.

TALANTA (2016)

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Article Cell & Tissue Engineering

CRISPR/Cas9-based genetic correction for recessive dystrophic epidermolysis bullosa

Beau R. Webber et al.

NPJ REGENERATIVE MEDICINE (2016)

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Article Pharmacology & Pharmacy

How Does In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

Trevor N. Johnson et al.

DRUG METABOLISM AND DISPOSITION (2016)

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Article Engineering, Biomedical

Triazine-modified dendrimer for efficient TRAIL gene therapy in osteosarcoma

Yu Wang et al.

ACTA BIOMATERIALIA (2015)

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Article Engineering, Biomedical

Tumor microenvironment sensitive doxorubicin delivery and release to glioma using angiopep-2 decorated gold nanoparticles

Shaobo Ruan et al.

BIOMATERIALS (2015)

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Article Pharmacology & Pharmacy

Formulations for children: problems and solutions

Hannah K. Batchelor et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2015)

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Review Biotechnology & Applied Microbiology

Challenges in CRISPR/CAS9 Delivery: Potential Roles of Nonviral Vectors

Ling Li et al.

HUMAN GENE THERAPY (2015)

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Article Pharmacology & Pharmacy

The STEP database through the end-users eyes-USABILITY STUDY

Smita Salunke et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2015)

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Article Medicine, General & Internal

Outcomes Following Gene Therapy in Patients With Severe Wiskott-Aldrich Syndrome

Salima Hacein-Bey Abina et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2015)

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Review Pharmacology & Pharmacy

Hyaluronic acid targeting of CD44 for cancer therapy: from receptor biology to nanomedicine

George Mattheolabakis et al.

JOURNAL OF DRUG TARGETING (2015)

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Editorial Material Pediatrics

Definition of a Pediatrician

Mary Ellen Rimsza et al.

PEDIATRICS (2015)

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Review Pediatrics

Safety of Excipients in Pediatric Formulations-A Call for Toxicity Studies in Juvenile Animals?

Georg Schmitt

CHILDREN-BASEL (2015)

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Review Pharmacology & Pharmacy

Nanoemulsions in Translational Research-Opportunities and Challenges in Targeted Cancer Therapy

Srinivas Ganta et al.

AAPS PHARMSCITECH (2014)

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Review Pharmacology & Pharmacy

Playing hide and seek with poorly tasting paediatric medicines: Do not forget the excipients

Jennifer Walsh et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Effective use of transdermal drug delivery in children

M. Begona Delgado-Charro et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Oral transmucosal drug delivery for pediatric use

Jenny K. W. Lam et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Paediatric drug development: The impact of evolving regulations

M. A. Turner et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Gene and cell therapy for children - New medicines, new challenges?

Karen F. Buckland et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Nanomedicines in the future of pediatric therapy

Alejandro Sosnik et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Pharmacokinetic/pharmacodynamic modelling approaches in paediatric infectious diseases and immunology

Charlotte I. S. Barker et al.

ADVANCED DRUG DELIVERY REVIEWS (2014)

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Review Pharmacology & Pharmacy

Patient-Centred Pharmaceutical Design to Improve Acceptability of Medicines: Similarities and Differences in Paediatric and Geriatric Populations

Fang Liu et al.

DRUGS (2014)

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Article Biochemistry & Molecular Biology

Carboplatin loaded protein nanoparticles exhibit improve anti-proliferative activity in retinoblastoma cells

Farhan Ahmed et al.

INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES (2014)

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Article Oncology

Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India

A. A. Ranade et al.

ANNALS OF ONCOLOGY (2013)

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Article Pharmacology & Pharmacy

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: Part 2-The pilot version

Smita Salunke et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2013)

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Article Oncology

Preclinical Evaluation of Genexol-PM, a Nanoparticle Formulation of Paclitaxel, as a Novel Radiosensitizer for the Treatment of Non-Small Cell Lung Cancer

Michael E. Werner et al.

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS (2013)

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Article Medicine, Research & Experimental

Dexamethasone-Loaded Block Copolymer Nanoparticles Induce Leukemia Cell Death and Enhance Therapeutic Efficacy: A Novel Application in Pediatric Nanomedicine

Vinu Krishnan et al.

MOLECULAR PHARMACEUTICS (2013)

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Article Biotechnology & Applied Microbiology

Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines

Falk Ehmann et al.

NANOMEDICINE (2013)

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Article Multidisciplinary Sciences

Lentiviral Hematopoietic Stem Cell Gene Therapy in Patients with Wiskott-Aldrich Syndrome

Alessandro Aiuti et al.

SCIENCE (2013)

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Article Multidisciplinary Sciences

Lentiviral Hematopoietic Stem Cell Gene Therapy Benefits Metachromatic Leukodystrophy

Alessandra Biffi et al.

SCIENCE (2013)

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Editorial Material Hematology

Whither Advanced Therapy Medicinal Products?

Mark D. Smith et al.

TRANSFUSION MEDICINE AND HEMOTHERAPY (2013)

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Review Pharmacology & Pharmacy

Off-Label Drug Use in Pediatric Patients

E. Kimland et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2012)

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Article Pharmacology & Pharmacy

The STEP (Safety and Toxicity of Excipients for Paediatrics) database. Part 1-A need assessment study

Smita Salunke et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2012)

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Review Chemistry, Multidisciplinary

Doxil® - The first FDA-approved nano-drug: Lessons learned

Yechezkel (Chezy) Barenholz

JOURNAL OF CONTROLLED RELEASE (2012)

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Review Dermatology

Applications of Nanotechnology in Dermatology

Lisa A. DeLouise

JOURNAL OF INVESTIGATIVE DERMATOLOGY (2012)

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Editorial Material Medicine, General & Internal

HISTORY OF MEDICINE Reform, Regulation, and Pharmaceuticals - The Kefauver-Harris Amendments at 50

Jeremy A. Greene et al.

NEW ENGLAND JOURNAL OF MEDICINE (2012)

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Review Polymer Science

Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier

Hirenkumar K. Makadia et al.

POLYMERS (2011)

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Article Pharmacology & Pharmacy

Factors and Mechanisms for Pharmacokinetic Differences between Pediatric Population and Adults

Eva Fernandez et al.

Pharmaceutics (2011)

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Article Engineering, Biomedical

A chitosan hydrogel delivery system for osteosarcoma gene therapy with pigment epithelium-derived factor combined with chemotherapy

Hang T. Ta et al.

BIOMATERIALS (2009)

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Article Multidisciplinary Sciences

Hematopoietic Stem Cell Gene Therapy with a Lentiviral Vector in X-Linked Adrenoleukodystrophy

Nathalie Cartier et al.

SCIENCE (2009)

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Review Pharmacology & Pharmacy

Using ontogeny information to build predictive models for drug elimination

Jane Alcorn et al.

DRUG DISCOVERY TODAY (2008)

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Review Pharmacology & Pharmacy

Developing paediatric medicines: identifying the needs and recognizing the challenges

Terry B. Ernest et al.

JOURNAL OF PHARMACY AND PHARMACOLOGY (2007)

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Review Pharmacology & Pharmacy

Translating pharmacogenetics and pharmacogenomics into drug development for clinical pediatrics and beyond

JS Leeder

DRUG DISCOVERY TODAY (2004)

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Article Clinical Neurology

Children versus adults: Pharmacokinetic and adverse-effect differences

GD Anderson

EPILEPSIA (2002)

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