☆ 4.6 Review

New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science

FRONTIERS IN MEDICINE (2023)

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Article Pharmacology & Pharmacy

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists

Victoria Gershuny et al.

Summary: This study combines modeling and experimentation to evaluate the dose-response relationship of the biomarker eosinophils, and the simulation results demonstrate the sensitivity of eosinophils as a PD biomarker and highlight the utility of model-based approaches in supporting biosimilar development.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Article Pharmacology & Pharmacy

Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics

Paula L. L. Hyland et al.

Summary: Proteomics is used to identify pharmacodynamic biomarkers for biosimilars evaluation. The study evaluated the utility of proteomic assay for interferon-beta 1a products and identified potential candidate biomarkers. This research supports clinical pharmacology studies of biosimilars with complex mechanisms or without previously characterized biomarkers.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Review Pharmacology & Pharmacy

Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

David G. Strauss et al.

Summary: This article introduces the definition of biosimilars and their importance in enhancing treatment options for patients. It also discusses the application of pharmacodynamic biomarkers in biosimilar development, as well as the considerations for study design and evidence. The article also reviews the FDA's regulatory science activities related to pharmacodynamic biomarkers for biosimilars conducted in support of their Biosimilars Action Plan.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Article Pharmacology & Pharmacy

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors

Morasa Sheikhy et al.

Summary: The FDA guidance on biosimilars development suggests that comparative clinical efficacy studies can be replaced by pharmacokinetic (PK) and pharmacodynamic (PD) similarity studies. However, there is a lack of PD comparability studies in biosimilar development, making it unclear how to plan these studies effectively.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Article Pharmacology & Pharmacy

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products

Jeffry Florian et al.

Summary: The FDA has taken steps to enhance the development of biosimilars by providing guidance on the use of pharmacokinetic and pharmacodynamic (PD) similarity study data. In a clinical study, the potential role of PD biomarkers in biosimilar development was evaluated using interferon beta-1a and pegylated interferon beta-1a. Both PD biomarkers showed increased levels after product administration, supporting their usefulness in a PD similarity study design.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Review Pharmacology & Pharmacy

Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary

Jeffry Florian et al.

Summary: The US FDA Biosimilars Guidance allows for the approval of biosimilars based on clinical pharmacokinetic and pharmacodynamic biomarker data without comparative clinical studies. To promote the use of pharmacodynamic biomarkers in biosimilar development, a two-day workshop was held by the Duke-Margolis Center for Health Policy and the FDA. The workshop aimed to discuss the current and future role of biomarkers and share experiences and research efforts in the field.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2023)

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Article Pharmacology & Pharmacy

In Vitro Testing of Sunscreens for Dermal Absorption: Method Comparison and Rank Order Correlation with In Vivo Absorption

Yang Yang et al.

Summary: This study compares two in vitro permeation test methods and examines the correlation between in vitro and in vivo absorption of sunscreen UV filters. The results show that all UV filters are absorbed by the skin following a single-dose application, and the amount of absorption varies among different filters. The in vitro permeation test using a single finite dose and heat-separated human epidermis correlates well with clinical data.

AAPS PHARMSCITECH (2022)

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Review Pharmacology & Pharmacy

Expanding Approved Patient Populations for Rare Disease Treatment Using In Vitro Data

James L. Weaver et al.

Summary: In vitro cell-based data can be used to extend pharmaceutical approval to patient subsets with unique genetic variants, given that certain conditions are met. These conditions include a clear description of the disease mechanism, understanding of the impact of variants on protein function, and demonstrating the impracticality of clinical trials for the variants in question. Additionally, the safety and efficacy of the drug should be well-established through controlled clinical trials, and the assay system should be qualified and validated to predict targeted therapy outcomes.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Pharmacology & Pharmacy

Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology-A Proof-of-Concept Model Development for Remdesivir

Mohammadreza Samieegohar et al.

Summary: This study proposes a mechanism-based, quantitative framework for translating nonclinical findings to clinical outcomes. It demonstrates the possibility of quantitatively predicting clinical outcomes based on nonclinical data and mechanistic understanding of the disease. The framework provides a modularized approach to aid in candidate drug selection and clinical trial design for COVID-19 therapeutics.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Pharmacology & Pharmacy

Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest

John Mann et al.

Summary: This study presents a mechanistic model that combines opioid receptor binding kinetics, pharmacokinetics, and human physiology to evaluate naloxone dosing for reversing respiratory depression caused by fentanyl and its derivatives. The model was validated and showed promising results in predicting the displacement of opioids by naloxone, hypoxia-induced cardiac arrest, and opioid-induced respiratory depression. The study found that carfentanil was more difficult to reverse compared to fentanyl and highlighted the importance of naloxone formulation in determining its effectiveness.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Pharmacology & Pharmacy

Analysis of secondary pharmacology assays received by the US Food and Drug Administration

Christina Scott et al.

Summary: Secondary pharmacology studies are an efficient and cost-effective method for evaluating the safety profile of a new drug. This study analyzed the secondary pharmacology results received by the FDA as part of Investigational New Drug (IND) submissions. The findings showed the most commonly tested target was the histamine 1 receptor, the most hit target was the sodium channel site 2, and the target with the highest hit percentage was the vesicular monoamine transporter 2. The study also highlighted the importance of improving the submission process for secondary pharmacology data to enhance regulatory review and early identification of safety issues.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2022)

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Article Medicine, General & Internal

Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia A Randomized Clinical Trial

Jeffry Florian et al.

Summary: This study aimed to investigate whether combining paroxetine or quetiapine with oxycodone would decrease the ventilatory response to hypercapnia, with findings showing that paroxetine plus oxycodone significantly decreased the ventilatory response on days 1 and 5, while quetiapine plus oxycodone did not have the same effect.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2022)

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Article Pharmacology & Pharmacy

Development of QSAR models to predict blood-brain barrier permeability

Sadegh Faramarzi et al.

Summary: Two statistical-based quantitative structure-activity relationship (QSAR) models were developed in this study to predict drug permeability across the blood-brain barrier (BBB). By using in vivo data and cross-validation, these models showed good performance in sensitivity and negative predictivity, making them a useful tool to reduce the use of experimental animals.

FRONTIERS IN PHARMACOLOGY (2022)

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Article Pharmacology & Pharmacy

Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting

Peter Schotland et al.

Summary: The study enhanced a model to predict adverse events on drug labels at approval, using more drugs, features, and a new algorithm. Evaluating comparator drugs with similar target activities helped assess the risk of adverse events for the drug of interest.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

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Review Medicine, Research & Experimental

Microengineered systems with iPSC-derived cardiac and hepatic cells to evaluate drug adverse effects

Keri Dame et al.

Summary: Current models predicting drug adverse effects often fail due to the variability of iPSC-derived hepatic and cardiac cells, which do not fully mimic adult primary tissues. Microfluidic systems have potential to improve differentiation protocols and enhance the physiological relevance of iPSC-derived cells, aiding in drug development programs. Further development and standardization of technologies can lead to more accurate in vitro models for evaluating drug effects.

EXPERIMENTAL BIOLOGY AND MEDICINE (2021)

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Article Medicine, Research & Experimental

Characterizing the reproducibility in using a liver microphysiological system for assaying drug toxicity, metabolism, and accumulation

Andres Rubiano et al.

Summary: The study characterized the reproducibility of liver microphysiological systems (MPSs) in predicting hepatic drug effects through experiments on drug toxicity, metabolism, and intracellular accumulation. The results demonstrated that the liver MPS can reliably produce consistent experimental outcomes for drug evaluation applications, showing better stability and functionality compared to other culture platforms. The study also provided general considerations and recommendations for using liver MPSs in drug development.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2021)

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Review Medicine, Legal

Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?

P. Suresh Jayasekara et al.

Summary: The ICH M7 (R1) guideline recommends the use of complementary (Q)SAR models to assess mutagenic potential of drug impurities, with expert knowledge playing a crucial role in overturning and resolving predictions, especially for low confidence predictions.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2021)

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Article Multidisciplinary Sciences

How μ-opioid receptor recognizes fentanyl

Quynh N. Vo et al.

Summary: This research elucidates the detailed binding mechanism of fentanyl in mOR, identifying a secondary binding mode that is only accessible when His297 is in a neutral HID tautomer state.

NATURE COMMUNICATIONS (2021)

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Article Public, Environmental & Occupational Health

Emergence of nosocomial associated opportunistic pathogens in the gut microbiome after antibiotic treatment

Isaac Raplee et al.

Summary: The study aimed to confirm gut microbiota shifts in an animal model of antibiotic treatment and found that antibiotic therapy reduced detectable species of bacteria and increased opportunistic pathogens in the gut microbiota. Furthermore, antibiotic treatment selected for antibiotic-resistant gene enriched subpopulations for many of these pathogens.

ANTIMICROBIAL RESISTANCE AND INFECTION CONTROL (2021)

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Article Biochemical Research Methods

Novel simultaneous method for the determination of avobenzone and oxybenzone in human plasma by UHPLC-MS/MS with phospholipid removal pretreatment: An application to a sunscreen clinical trial

Nageswara R. Pilli et al.

Summary: A sensitive and specific LC-MS/MS method was developed for simultaneous determination of avobenzone and oxybenzone in human plasma to support a clinical study conducted by the FDA on systemic exposure of sunscreen active ingredients.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2021)

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Article Medicine, Research & Experimental

Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat

Lin Xu et al.

Summary: This study utilized a nonclinical in vivo model to assess the impact on respiration of non-benzodiazepine sedative psychotropic drugs when used concurrently with opioids. It found that paroxetine, trazodone, and quetiapine given with oxycodone significantly increased arterial partial pressure of carbon dioxide, potentially due to pharmacokinetic interactions. The study identified drug-drug interaction effects depressing respiration in an animal model when quetiapine or paroxetine were co-administered with oxycodone, highlighting the importance of further clinical pharmacodynamic drug interaction studies.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE (2021)

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Article Medicine, General & Internal

Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA) A Randomized Clinical Trial

Jeffry Florian et al.

Summary: This study involving 18 healthy participants found that oral ranitidine did not significantly increase urinary excretion of NDMA compared to placebo under different dietary conditions.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2021)

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Review Medicine, Legal

Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future

Ronald L. Wange et al.

Summary: Traditional safety testing of pharmaceutical candidates relies on data from animal studies, but there are ethical implications in using animals for testing. FDA supports the 3Rs principles of replace, reduce, refine in animal usage. Ongoing efforts are being made to achieve the mission as humanely as possible in pharmaceutical development.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2021)

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Article Biochemical Research Methods

Simultaneous quantification of dexamethasone and 6β-hydroxydexamethasone in rabbit plasma, aqueous and vitreous humor, and retina by UHPLC-MS/MS

Jianghong Gu et al.

Summary: The aim of this study was to develop and validate a method for the simultaneous determination of dexamethasone and its metabolite in rabbit plasma and ocular matrices, and it was found to be fit-for-purpose with a low limit of quantitation.

BIOANALYSIS (2021)

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Article Pharmacology & Pharmacy

Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration

Andrew Dodson et al.

Summary: Secondary pharmacology studies are used by the pharmaceutical industry to identify safety concerns of drugs before clinical trials. The results of these studies often align with previous findings, but there is room for improvement in the submission process by industry.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2021)

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Article Pharmacology & Pharmacy

Characterization of a commercially available line of iPSC hepatocytes as models of hepatocyte function and toxicity for regulatory purposes

Hisham Qosa et al.

Summary: The study assessed the similarities and differences between iPSC-heps and Prim-heps in drug metabolism, hepatotoxicity, and drug transport. While all culture models showed similar basal CYP activity, Prim-heps were generally more sensitive to CYP inducing agents. iPSC-heps appear useful for toxicity and transport studies, but may not be optimal for metabolism studies.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2021)

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Article Medicine, General & Internal

In Vitro Analysis of N-Nitrosodimethylamine (NDMA) Formation From Ranitidine Under Simulated Gastrointestinal Conditions

Zongming Gao et al.

Summary: The study found that conversion of ranitidine to NDMA was not detected until nitrite concentration reached 5000 μmol/L, which is 50-fold greater than the upper range of physiologic gastric nitrite concentrations at acidic pH. These findings suggest that ranitidine is not converted to NDMA in gastric fluid under physiologic conditions.

JAMA NETWORK OPEN (2021)

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Article Chemistry, Multidisciplinary

Kinetics and Mechanism of Fentanyl Dissociation from the μ-Opioid Receptor

Paween Mahinthichaichan et al.

Summary: Driven by illicit fentanyl, opioid-related deaths have reached the highest level in 2020. Naloxone is currently used to rescue opioid overdoses by competitively binding and antagonizing the mu-opioid receptor. By applying enhanced sampling molecular dynamics techniques, the study calculated the fentanyl-mOR dissociation time and elucidated the mechanism, highlighting the role of different protonation states of H297(6.52) in affecting fentanyl behavior.

JACS AU (2021)

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Editorial Material Pharmacology & Pharmacy

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Junyi Li et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Article Pharmacology & Pharmacy

General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy

Zhihua Li et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Article Infectious Diseases

Effect of drug combinations on the kinetics of antibiotic resistance emergence in Escherichia coli CFT073 using an in vitro hollow-fibre infection model

Narayana Garimella et al.

INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS (2020)

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Article Medicine, General & Internal

Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients A Randomized Clinical Trial

Murali K. Matta et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2020)

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Article Multidisciplinary Sciences

Evaluating kratom alkaloids using PHASE

Christopher R. Ellis et al.

PLOS ONE (2020)

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Article Biochemical Research Methods

Predicting potential adverse events using safety data from marketed drugs

Chathuri Daluwatte et al.

BMC BIOINFORMATICS (2020)

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Article Multidisciplinary Sciences

Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells

James Kramer et al.

SCIENTIFIC REPORTS (2020)

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Article Medicine, Legal

Development of improved QSAR models for predicting the outcome of the in vivo micronucleus genetic toxicity assay

Jae Wook Yoo et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2020)

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Article Medicine, Legal

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Amy M. Avila et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2020)

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Article Pharmacology & Pharmacy

A general procedure to select calibration drugs for lab-specific validation and calibration of proarrhythmia risk prediction models: An illustrative example using the CiPA model

Xiaomei Han et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2020)

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Article Pharmacology & Pharmacy

Quantifying drug-induced structural toxicity in hepatocytes and cardiomyocytes derived from hiPSCs using a deep learning method

Mahnaz Maddah et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2020)

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Article Pharmacology & Pharmacy

Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative

Zhihua Li et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

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Article Pharmacology & Pharmacy

The Potential Role of the J-Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium

Jose Vicente et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Article Toxicology

BLT-Immune Humanized Mice as a Model for Nivolumab-Induced Immune-Mediated Adverse Events: Comparison of the NOG and NOG-EXL Strains

James L. Weaver et al.

TOXICOLOGICAL SCIENCES (2019)

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Article Pharmacology & Pharmacy

Evaluation of a TGN1412 analogue using in vitro assays and two immune humanized mouse models

Hangyi Yan et al.

TOXICOLOGY AND APPLIED PHARMACOLOGY (2019)

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Article Pharmacology & Pharmacy

Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using Public Health Assessment via Structural Evaluation

Christopher R. Ellis et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

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Review Pharmacology & Pharmacy

Liver Microphysiological Systems for Predicting and Evaluating Drug Effects

Alexandre J. S. Ribeiro et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

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Article Medicine, General & Internal

Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients A Randomized Clinical Trial

Murali K. Matta et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2019)

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Review Pharmacology & Pharmacy

Drug-Drug Interaction Studies of Methadone and Antiviral Drugs: Lessons Learned

Islam R. Younis et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2019)

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Article Medical Laboratory Technology

Bone marrow-liver-thymus (BLT) immune humanized mice as a model to predict cytokine release syndrome

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TRANSLATIONAL RESEARCH (2019)

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Editorial Material Medicine, Research & Experimental

Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

Yow-Ming C. Wang et al.

BIOMARKERS IN MEDICINE (2019)

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Review Pharmacology & Pharmacy

Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms

Brian D. Guth et al.

FRONTIERS IN PHARMACOLOGY (2019)

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Review Pharmacology & Pharmacy

Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes

Alexandre J. S. Ribeiro et al.

FRONTIERS IN PHARMACOLOGY (2019)

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Editorial Material Medical Informatics

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G. Strauss et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2019)

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Article Pharmacology & Pharmacy

Drug potency on inhibiting late Na+ current is sensitive to gating modifier and current region where drug effects were measured

Min Wu et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2019)

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Article Pharmacology & Pharmacy

Assessment of Multi-Ion Channel Block in a Phase I Randomized Study Design: Results of the CiPA Phase I ECG Biomarker Validation Study

Jose Vicente et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2019)

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Article Medicine, Legal

Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses

Curran Landry et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2019)

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Review Medical Informatics

Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science

Rodney Rouse et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2018)

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Article Toxicology

Cross-Site Reliability of Human Induced Pluripotent stem cell-derived Cardiomyocyte Based Safety Assays Using Microelectrode Arrays: Results from a Blinded CiPA Pilot Study

Daniel Millard et al.

TOXICOLOGICAL SCIENCES (2018)

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Article Biochemical Research Methods

Novel and rapid LC-MS/MS method for quantitative analysis of methylphenidate in dried blood spots

Adarsh Gandhi et al.

BIOANALYSIS (2018)

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Review Chemistry, Medicinal

Methadone Metabolism and Drug-Drug Interactions: In Vitro and In Vivo Literature Review

Donna A. Volpe et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2018)

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Letter Medicine, General & Internal

Neural-Tube Defects with Dolutegravir Treatment from the Time of Conception

Rebecca Zash et al.

NEW ENGLAND JOURNAL OF MEDICINE (2018)

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Article Medicine, Legal

Construction and application of (Q)SAR models to predict chemical-induced in vitro chromosome aberrations

Chia-Wen Hsu et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2018)

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Article Cell Biology

International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment

Ksenia Blinova et al.

CELL REPORTS (2018)

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Article Pharmacology & Pharmacy

Target-Adverse Event Profiles to Augment Pharmacovigilance: A Pilot Study With Six New Molecular Entities

Peter Schotland et al.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2018)

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Review Pharmacology & Pharmacy

Mechanistic Model-Informed Proarrhythmic Risk Assessment of Drugs: Review of the CiPA Initiative and Design of a Prospective Clinical Validation Study

Jose Vicente et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2018)

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Review Pharmacology & Pharmacy

Naloxone dosage for opioid reversal: current evidence and clinical implications

Rachael Rzasa Lynn et al.

THERAPEUTIC ADVANCES IN DRUG SAFETY (2018)

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The ChEMBL database in 2017

Anna Gaulton et al.

NUCLEIC ACIDS RESEARCH (2017)

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Article Toxicology

Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced Arrhythmias

Ksenia Blinova et al.

TOXICOLOGICAL SCIENCES (2017)

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Article Physiology

Uncertainty Quantification Reveals the Importance of Data Variability and Experimental Design Considerations for in Silico Proarrhythmia Risk Assessment

Kelly C. Chang et al.

FRONTIERS IN PHYSIOLOGY (2017)

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Article Physiology

Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

Sara Dutta et al.

FRONTIERS IN PHYSIOLOGY (2017)

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Article Cardiac & Cardiovascular Systems

Improving the In Silico Assessment of Proarrhythmia Risk by Combining hERG (Human Ether-a-go-go-Related Gene) Channel-Drug Binding Kinetics and Multichannel Pharmacology

Zhihua Li et al.

CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY (2017)

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Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial

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CLINICAL PHARMACOLOGY & THERAPEUTICS (2016)

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Article Medicine, General & Internal

A Proactive Response to Prescription Opioid Abuse

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NEW ENGLAND JOURNAL OF MEDICINE (2016)

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Article Medicine, Legal

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses

Alexander Amberg et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2016)

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Article Pharmacology & Pharmacy

An evaluation of 30 clinical drugs against the comprehensive in vitro proarrhythmia assay (CiPA) proposed ion channel panel

William J. Crumb et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2016)

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Article Pharmacology & Pharmacy

The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative Update on progress

Thomas Colatsky et al.

JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS (2016)

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Article Multidisciplinary Sciences

Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk

Lars Johannesen et al.

PLOS ONE (2016)

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Article Cardiac & Cardiovascular Systems

Sex differences in drug-induced changes in ventricular repolarization

Jose Vicente et al.

JOURNAL OF ELECTROCARDIOLOGY (2015)

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Article Medicine, Legal

Establishing best practise in the application of expert review of mutagenicity under ICH M7

Chris Barber et al.

REGULATORY TOXICOLOGY AND PHARMACOLOGY (2015)

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Article Cardiac & Cardiovascular Systems

Comprehensive T wave Morphology Assessment in a Randomized Clinical Study of Dofetilide, Quinidine, Ranolazine, and Verapamil

Jose Vicente et al.

JOURNAL OF THE AMERICAN HEART ASSOCIATION (2015)

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Article Pharmacology & Pharmacy

Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory Science

L. Johannesen et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2014)

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Article Pharmacology & Pharmacy

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