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The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives

PHARMACEUTICAL RESEARCH (2022)

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Article Pharmacology & Pharmacy

Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen

I Camara-Martinez et al.

Summary: This study demonstrates the use of a mechanistic model based on mass balance and ionization equilibria to calculate the pH of the particle surface under different buffer conditions. The discrepancies in surface pH between the reference and test tablets are crucial for establishing in vitro-in vivo correlation. Additionally, this study shows the potential of dissolution methods for obtaining in vitro-in vivo correlation for BCS class IIa drugs and for extending BCS biowaivers to BCS class IIa drugs.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2022)

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Article Chemistry, Medicinal

Mechanistic Models for USP2 Dissolution Apparatus, Including Fluid Hydrodynamics and Sedimentation

Xavier Pepin et al.

Summary: This study aims to improve the prediction of drug product dissolution by proposing new hydrodynamic models and estimating the impact of formulation and drug sedimentation or coning. The models were validated on 166 dissolution experiments and 18 different drugs, showing satisfactory predictive power with improved precision in experiments where coning was suspected.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

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Article Chemistry, Medicinal

Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption

Marc Laisney et al.

Summary: A physiologically based biopharmaceutics model was developed to support the formulation development of ribociclib, a CDK4/6 inhibitor. The model accurately predicted the pharmacokinetics and bioequivalence of ribociclib in healthy volunteers and cancer patients, providing valuable insights for formulation optimization and clinical studies.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

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Article Chemistry, Medicinal

Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling

Mauricio A. Garcia et al.

Summary: Highly variable disposition after oral ingestion of acyclovir has been reported, and the activity of OCT1 may partially explain the pharmacokinetic differences among populations. In addition, the dissolution rate of Chilean generics was slower, but their bioequivalence was correctly predicted.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

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Article Medicine, Research & Experimental

Lilly Absorption Modeling Platform: A Tool for Early Absorption Assessment

Stephen D. Stamatis et al.

Summary: Oral drug absorption modeling has rapidly advanced in the past 40 years, with compartmental approaches and the new noncompartmental absorption modeling framework LAMP being the main focus. LAMP connects a well-mixed stomach to a continuous tube model of the small intestine, incorporating intestinal mixing and a highly tunable precipitation model.

MOLECULAR PHARMACEUTICS (2022)

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Article Pharmacology & Pharmacy

Physiologically based pharmacokinetic modelling of treprostinil after intravenous injection and extended-release oral tablet administration in healthy volunteers: An extrapolation to other patient populations including patients with hepatic impairment

Xuemei Wu et al.

Summary: The study aimed to develop a robust physiologically based pharmacokinetic (PBPK) model for treprostinil intravenous injection and extended-release tablet to optimize treprostinil pharmacotherapy in patients. The model successfully predicted drug disposition in humans and reliability in patient populations with hepatic impairment was documented. This model has potential for use in predicting pharmacokinetics in other special patient populations.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Review Pharmacology & Pharmacy

Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

Eleftheria Tsakalozou et al.

Summary: Physiologically-based pharmacokinetic (PBPK) modeling and simulation is used to predict the pharmacokinetics of drugs, particularly in the skin following topical application. These models can help regulators and product developers identify factors affecting local and systemic exposure. In the generic drug field, the use of dermal PBPK modeling to support alternative bioequivalence approaches is increasing. This report discusses the scientific considerations for the development, verification, and validation (V&V) of PBPK models for dermatological drug products.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Chemistry, Medicinal

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

Xavier J. H. Pepin et al.

Summary: This article summarizes the proceedings of a three-day workshop discussing the challenges in developing and implementing in vitro biopredictive tools, best practices in model development, verification and validation, and the applications of PBBM in supporting drug product quality.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Chemistry, Medicinal

The Provisional No-Effect Threshold of Sugar Alcohols on Oral Drug Absorption Estimated by Physiologically Based Biopharmaceutics Model

Miki Yamane et al.

Summary: Sugar alcohols reduce oral drug bioavailability through osmotic effects, with varying impacts on different drugs. Modeling and simulation approaches revealed that a high systemic elimination rate is crucial for reducing maximum plasma concentration, while a sugar alcohol level below 400 mg had minimal effects on the pharmacokinetics of most sensitive drugs.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Review Pharmacology & Pharmacy

Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy

Adam S. Darwich et al.

Summary: Model-informed precision dosing (MIPD) is a modern approach to individualizing drug therapy, focusing on the characteristics of each patient rather than a one-size-fits-all alternative. This review covers the historical perspective on dose variability, technical aspects of MIPD, novel approaches to patient variability, and current debates on MIPD.

ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 61, 2021 (2021)

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Article Pharmacology & Pharmacy

Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol

Joyce S. Macwan et al.

Summary: This study evaluated the impact of in vitro dissolution on the clinical performance of bisoprolol using a physiologically based pharmacokinetics model and demonstrated that in vitro dissolution was not critical for the clinical performance of bisoprolol over a wide range of tested values. Safe space expansion was explored using hypothetical dissolution data, showing that a formulation with specific dissolution rates could be considered bioequivalent to the classical fast dissolution of bisoprolol based on virtual bioequivalence trials.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2021)

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Article Chemistry, Medicinal

A Biopharmetrics Approach for Drug Product Quality Control with Clinical Relevance

John Z. Duan

Summary: The study utilized a Biopharmetrics approach to establish a model connecting raw material attributes, dissolution, and in vivo exposure, predicting exposure ratios for future batches and defining clinically meaningful limits for raw material quality control. Through these exercises, the subdiscipline of Biopharmetrics was introduced and discussed.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Chemistry, Medicinal

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

Neil Parrott et al.

Summary: This workshop report summarizes the proceedings of the second day of a workshop on translational modeling strategies in drug product development, manufacturing changes, and controls. The focus of the day was on best practices related to PBBM, including development, verification, and validation.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Pharmacology & Pharmacy

Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs

Min Li et al.

Summary: The study investigated the in vivo drug dissolution kinetics of BCS Class 2a IR solid oral drug products, revealing that solubility has minimal impact on in vivo drug dissolution rate. NSAIDs typically exhibit rapid and complete in vivo drug dissolution in the small intestine, with gastric emptying and the migrating motor complex likely governing drug dissolution and absorption in a fasted state.

AAPS JOURNAL (2021)

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Article Pharmacology & Pharmacy

Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach

Xavier J. H. Pepin et al.

Summary: The article discusses how a middle-out modeling approach, combining in vitro-based predictions with clinical data, can successfully predict the impact of food on drug absorption. By adjusting drug clearance mechanisms and refining solubility, factors affecting absorption and exposure limitations were analyzed based on literature data.

AAPS JOURNAL (2021)

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Article Pharmacology & Pharmacy

Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters

Brahim Achour et al.

Summary: Variability in hepatic drug metabolism and disposition is well recognized, and this study successfully developed a liquid biopsy technology for assessing individual patient's capacity. The technology showed reliable patient stratification and utility in adjusting drug dose for achieving similar drug exposure between patients with variable hepatic elimination.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2021)

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Article Pharmacology & Pharmacy

The evaluation of the effect of different superdisintegrants on the drug release from FDM 3D printed tablets through different applied strategies: In vitro-in silico assessment

Marija Duranovic et al.

Summary: Four strategies were applied to accelerate drug release from paracetamol-loaded tablets printed using fused deposition modelling. The best results were achieved by combining Kollidon CL and mannitol as release enhancers, which significantly accelerated drug release and absorption, meeting the criteria for immediate release tablets.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2021)

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Article Pharmacology & Pharmacy

Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the US Food and Drug Administration for New Drugs

Fang Wu et al.

Summary: The article summarizes the application of PBPK absorption modeling and simulation in drug product development, highlighting its significant role in establishing relationships between critical quality attributes. It also provides insights into future directions for the use of PBPK in drug product quality assessment based on analysis of NDA submissions.

AAPS JOURNAL (2021)

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Article Pharmacology & Pharmacy

Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach

Takao Komasaka et al.

Summary: The study investigated non-bioequivalent plasma concentration profiles among different dosage forms of the salt of raltegravir by utilizing biorelevant in vitro testing and commercial in silico software. The dissolution rate was found to be influenced by pre-exposure to an acidic environment, with tablets exhibiting slow dissolution compared to suspension. However, successful simulation of plasma concentration profiles was achieved when gastric emptying was considered as a key physiological factor.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Chemistry, Medicinal

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Amitava Mitra et al.

Summary: This report summarizes the discussions on translational modeling strategies to support drug product development, manufacturing changes and controls on Day 3 of the workshop. The focus was on patient-centric product development and the role of PBBM in establishing drug product specifications and its practical applications in drug product quality. Breakout session discussions covered topics related to terminology, regulatory harmonization, CRDPS approaches, and bridging between biorelevant and quality control dissolution methods.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Engineering, Chemical

PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment

Abigail Ferreira et al.

Summary: Pharmacokinetics plays a vital role in drug development, clinical optimization, and precision medicine, contributing to improved patient outcomes, reduced side effects, and prevention of resistant bacterial strains.

PROCESSES (2021)

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Article Chemistry, Medicinal

Evaluating the Impact of Physiological Properties of the Gastrointestinal Tract On Drug In Vivo Performance Using Physiologically Based Biopharmaceutics Modeling and Virtual Clinical Trials

Rebeka Jereb et al.

Summary: This study investigates the impact of gastrointestinal physiology on drug bioperformance, showing that variations in pH, fluid volume, bile salt concentration, and transit time can affect drug dissolution and absorption. By developing physiologically based absorption models and conducting virtual clinical trials, the study explores the reasons for variability in drug bioperformance between subjects and proposes ways to optimize drug design and efficacy based on these findings.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Medicine, Research & Experimental

Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs

Emma Eckernas et al.

Summary: This study investigated the ability of mechanistic physiologically based biopharmaceutics modeling to predict regional and colon absorption of drugs in dogs with sufficient accuracy, in order to replace in vivo dog studies for the early assessment of colon absorption limitation risks. The results showed that both GI-Sim and GastroPlus models were able to predict regional differences in absorption, as well as AUC and relative bioavailability in the colon, with acceptable accuracy in an early development setting.

MOLECULAR PHARMACEUTICS (2021)

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Article Chemistry, Medicinal

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Tycho Heimbach et al.

Summary: This article discusses five case studies on using physiologically based biopharmaceutics modeling (PBBM) to establish safe spaces for oral drug products. It explores the challenges and methods in developing safe spaces and highlights the need for more case studies to drive the development of best practices.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

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Article Chemistry, Medicinal

Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets

Swati Jaiswal et al.

Summary: The study aimed to evaluate if changes in the dissolution specification of DRL ABC would still result in a bioequivalent product, using a PBPK model and in vitro-in vivo relationship. The results showed that the changes were justified and the product remained bioequivalent.

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY (2021)

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Article Pharmacology & Pharmacy

Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate

Nashid Farhan et al.

Summary: The exposure-response relationship of direct acting oral anti-coagulants (DOACs) for bleeding risk is steep relative to ischemic stroke reduction, with small changes in exposure potentially leading to bleeding events. Through developing and verifying a physiologically-based PK (PBPK) model, the impact of critical formulation parameters on the pharmacokinetics of dabigatran etexilate (DABE) was determined, revealing high sensitivity of DABE exposure to supersaturation ratio and precipitation kinetics.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2021)

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Article Chemistry, Medicinal

Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies

Amitava Mitra et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Editorial Material Pharmacology & Pharmacy

Virtual Twins: Understanding the Data Required for Model-Informed Precision Dosing

Thomas M. Polasek et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

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Article Pharmacology & Pharmacy

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

Ioannis Loisios-Konstantinidis et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Pharmacology & Pharmacy

A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

Marival Bermejo et al.

PHARMACEUTICS (2020)

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Article Chemistry, Medicinal

Evaluation of Differences in Dosage Form Performance of Generics Using BCS-Based Biowaiver Specifications and Biopharmaceutical Modeling-Case Examples Amoxicillin and Doxycycline

Martin A. Hofsaess et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Pharmacology & Pharmacy

Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

Lei Miao et al.

AAPS JOURNAL (2020)

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Article Pharmacology & Pharmacy

Physiologically based pharmacokinetic model outputs depend on dissolution data and their input: Case examples glibenclamide and dipyridamole

Lukas Klumpp et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Pharmacology & Pharmacy

Establishment of a clinically relevant specification for dissolution testing using physiologically based pharmacokinetic (PBPK) modeling approaches

Takafumi Kato et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo consortium commentary

Masoud Jamei et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

Exploring the Effect of Esomeprazole on Gastric and Duodenal Fluid Volumes and Absorption of Ritonavir

Tom de Waal et al.

PHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

Transverse comparison of mannitol content in marketed drug products: Implication for no -effect dose of sugar alcohols on oral drug absorption

Kazuki Matsui et al.

JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY (2020)

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Article Chemistry, Medicinal

Suitability of the z-Factor for Dissolution Simulation of Solid Oral Dosage Forms: Potential Pitfalls and Refinements

Martin A. Hofsass et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Medicine, Research & Experimental

Hierarchical Mass Transfer Analysis of Drug Particle Dissolution, Highlighting the Hydrodynamics, pH, Particle Size, and Buffer Effects for the Dissolution of Ionizable and Nonionizable Drugs in a Compendial Dissolution Vessel

Niloufar Salehi et al.

MOLECULAR PHARMACEUTICS (2020)

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Article Pharmacology & Pharmacy

The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets

Rafael L. M. Paraiso et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Pharmacology & Pharmacy

Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM)

Rebeka Jereb et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

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Article Pharmacology & Pharmacy

Consideration of a Credibility Assessment Framework in Model-Informed Drug Development: Potential Application to Physiologically-Based Pharmacokinetic Modeling and Simulation

Colleen Kuemmel et al.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2020)

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Article Mathematical & Computational Biology

Estimation of clinical trial success rates and related parameters

Chi Heem Wong et al.

BIOSTATISTICS (2019)

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Article Pharmacology & Pharmacy

In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration

James Butler et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2019)

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Article Chemistry, Medicinal

Effect of Amorphous Nanoparticle Size on Bioavailability of Anacetrapib in Dogs

Filippos Kesisoglou et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

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Article Pharmacology & Pharmacy

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part I. Mechanistic modelling of drug product dissolution to derive a P-PSD for PBPK model input

Xavier J. H. Pepin et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2019)

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Article Pharmacology & Pharmacy

Bridging in vitro dissolution and in vivo exposure for acalabrutinib. Part II. A mechanistic PBPK model for IR formulation comparison, proton pump inhibitor drug interactions, and administration with acidic juices

Xavier J. H. Pepin et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2019)

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Article Medicine, Research & Experimental

Application of the GastroDuo as an in Vitro Dissolution Tool To Simulate the Gastric Emptying of the Postprandial Stomach

Philipp Schick et al.

MOLECULAR PHARMACEUTICS (2019)

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Article Chemistry, Medicinal

Development of USP Apparatus 3 Dissolution Method with IVIVC for Extended Release Tablets of Metformin Hydrochloride and Development of a Generic Formulation

Thamara de Carvalho Mendes et al.

CHEMICAL & PHARMACEUTICAL BULLETIN (2019)

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Article Chemistry, Medicinal

Application of a Dynamic Fluid and pH Model to Simulate Intraluminal and Systemic Concentrations of a Weak Base in GastroPlus™

Bart Hens et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

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Editorial Material Pharmacology & Pharmacy

PBPK Absorption Modeling: Establishing the In Vitro-In Vivo LinkIndustry Perspective

Cordula Stillhart et al.

AAPS JOURNAL (2019)

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Article Pharmacology & Pharmacy

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Linka Workshop Summary Report

Tycho Heimbach et al.

AAPS JOURNAL (2019)

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Article Pharmacology & Pharmacy

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report

Andreas Abend et al.

AAPS JOURNAL (2018)

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Article Pharmacology & Pharmacy

Low dose caffeine as a salivary tracer for the determination of gastric water emptying in fed and fasted state: A MRI validation study

Maximilian Sager et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2018)

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Review Pharmacology & Pharmacy

Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded '21st Century BA/BE' project

Bart Hens et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2018)

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Article Chemistry, Medicinal

Using Computational Fluid Dynamics to Compare Shear Rate and Turbulence in the TIM-Automated Gastric Compartment With USP Apparatus II

Matthew Hopgood et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2018)

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Article Medicine, Research & Experimental

Gastric Emptying and Small Bowel Water Content after Administration of Grapefruit Juice Compared to Water and Isocaloric Solutions of Glucose and Fructose: A Four-Way Crossover MRI Pilot Study in Healthy Subjects

Michael Grimm et al.

MOLECULAR PHARMACEUTICS (2018)

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Article Pharmacology & Pharmacy

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Sandra Suarez-Sharp et al.

AAPS JOURNAL (2018)

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Article Pharmacology & Pharmacy

Mechanistic investigation of the negative food effect of modified release zolpidem

Cord J. Andreas et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2017)

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Article Medicine, Research & Experimental

Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug

Shriram M. Pathak et al.

MOLECULAR PHARMACEUTICS (2017)

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Article Medicine, Research & Experimental

Gastric Water Emptying under Fed State Clinical Trial Conditions Is as Fast as under Fasted Conditions

Michael Grimm et al.

MOLECULAR PHARMACEUTICS (2017)

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Review Chemistry, Multidisciplinary

A Review of Disintegration Mechanisms and Measurement Techniques

Daniel Markl et al.

PHARMACEUTICAL RESEARCH (2017)

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Article Pharmacology & Pharmacy

Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors

Jianghong Fan et al.

AAPS JOURNAL (2017)

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Article Pharmacology & Pharmacy

Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products

Zhanglin Ni et al.

AAPS JOURNAL (2017)

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Article Pharmacology & Pharmacy

Characterising Drug Release from Immediate-Release Formulations of a Poorly Soluble Compound, Basmisanil, Through Absorption Modelling and Dissolution Testing

Cordula Stillhart et al.

AAPS JOURNAL (2017)

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Article Pharmacology & Pharmacy

Semimechanistic Model Describing Gastric Emptying and Glucose Absorption in Healthy Subjects and Patients With Type 2 Diabetes

Oskar Alskar et al.

JOURNAL OF CLINICAL PHARMACOLOGY (2016)

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Review Pharmacology & Pharmacy

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

Sandra Suarez-Sharp et al.

AAPS JOURNAL (2016)

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Review Pharmacology & Pharmacy

Physical chemistry of supersaturated solutions and implications for oral absorption

Lynne S. Taylor et al.

ADVANCED DRUG DELIVERY REVIEWS (2016)

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Review Pharmacology & Pharmacy

Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new frontiers

Mirko Koziolek et al.

ADVANCED DRUG DELIVERY REVIEWS (2016)

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Article Chemistry, Medicinal

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug DevelopmentdIndustry Case Studies

Filippos Kesisoglou et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2016)

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Article Chemistry, Medicinal

Characterization of Human Duodenal Fluids in Fasted and Fed State Conditions

Danny Riethorst et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2016)

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Article Medicine, Research & Experimental

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

Xavier J. H. Pepin et al.

MOLECULAR PHARMACEUTICS (2016)

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Article Pharmacology & Pharmacy

Mechanism-Based Modeling of Gastric Emptying Rate and Gallbladder Emptying in Response to Caloric Intake

B. Guiastrennec et al.

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY (2016)

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Article Pharmacology & Pharmacy

Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate

Filippos Kesisoglou et al.

AAPS JOURNAL (2015)

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Article Pharmacology & Pharmacy

Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

Filippos Kesisoglou et al.

AAPS JOURNAL (2015)

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Article Pharmacology & Pharmacy

Inter-subject variability in intestinal drug solubility

Sarit Cohen Rabbie et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2015)

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Review Pharmacology & Pharmacy

Combining the 'bottom up' and 'top down' approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

Nikolaos Tsamandouras et al.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2015)

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Review Pharmacology & Pharmacy

Understanding Pharmaceutical Quality by Design

Lawrence X. Yu et al.

AAPS JOURNAL (2014)

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Article Pharmacology & Pharmacy

Physiologically Based Absorption Modelling to Predict the Impact of Drug Properties on Pharmacokinetics of Bitopertin

Neil Parrott et al.

AAPS JOURNAL (2014)

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Article Pharmacology & Pharmacy

Viscosity-mediated negative food effect on oral absorption of poorly-permeable drugs with an absorption window in the proximal intestine: In vitro experimental simulation and computational verification

Sandra Cvijic et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2014)

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Review Pharmacology & Pharmacy

PBPK models for the prediction of in vivo performance of oral dosage forms

Edmund S. Kostewicz et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2014)

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Article Chemistry, Medicinal

Application and Validation of an Advanced Gastrointestinal In Vitro Model for the Evaluation of Drug Product Performance in Pharmaceutical Development

Richard Barker et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2014)

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Article Medicine, Research & Experimental

Quantification of Gastrointestinal Liquid Volumes and Distribution Following a 240 mL Dose of Water in the Fasted State

Deanna M. Mudie et al.

MOLECULAR PHARMACEUTICS (2014)

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Article Chemistry, Medicinal

Compartmental absorption modeling and site of absorption studies to determine feasibility of an extended-release formulation of an HIV-1 attachment inhibitor phosphate ester prodrug

Jonathan Brown et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2013)

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Review Pharmacology & Pharmacy

Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

Barbara M. Davit et al.

AAPS JOURNAL (2012)

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Article Pharmacology & Pharmacy

Mechanistic investigation of food effect on disintegration and dissolution of BCS class III compound solid formulations: the importance of viscosity

Asma Radwan et al.

BIOPHARMACEUTICS & DRUG DISPOSITION (2012)

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Article Pharmacology & Pharmacy

A biorelevant in vitro release/permeation system for oral transmucosal dosage forms

Poonam R. Delvadia et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2012)

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Article Pharmacology & Pharmacy

Integration of dissolution into physiologically-based pharmacokinetic models III: PK-Sim®

Stefan Willmann et al.

JOURNAL OF PHARMACY AND PHARMACOLOGY (2012)

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Article Pharmacology & Pharmacy

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

Xinyuan Zhang et al.

AAPS JOURNAL (2011)

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Article Gastroenterology & Hepatology

Gastric transit and small intestinal transit time and motility assessed by a magnet tracking system

Jonas Worsoe et al.

BMC GASTROENTEROLOGY (2011)

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Article Pharmacology & Pharmacy

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

P. Zhao et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)

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Article Pharmacology & Pharmacy

Application of Physiologically Based Pharmacokinetic Modeling to Understanding the Clinical Pharmacokinetics of UK-369,003

Kenny J. Watson et al.

DRUG METABOLISM AND DISPOSITION (2011)

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Article Pharmacology & Pharmacy

Role of Physiological Intestinal Water in Oral Absorption

Steven C. Sutton

AAPS JOURNAL (2009)

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Article Chemistry, Multidisciplinary

Gastric Emptying of Pellets under Fasting Conditions: A Mathematical Model

Igor Locatelli et al.

PHARMACEUTICAL RESEARCH (2009)

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Review Pharmacology & Pharmacy

Clinical relevance of dissolution testing in quality by design

Paul A. Dickinson et al.

AAPS JOURNAL (2008)

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Article Pharmacology & Pharmacy

Bioavailability of amoxicillin and clavulanic acid from extended release tablets depends on intragastric tablet deposition and gastric emptying

W. Weitschies et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2008)

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Article Chemistry, Multidisciplinary

Oral absorption of poorly water-soluble drugs: Computer simulation of fraction absorbed in humans from a miniscale dissolution test

Ryusuke Takano et al.

PHARMACEUTICAL RESEARCH (2006)

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Article Chemistry, Multidisciplinary

Impact of the intragastric location of extended release tablets on food interactions

W Weitschies et al.

JOURNAL OF CONTROLLED RELEASE (2005)

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Article Gastroenterology & Hepatology

Intestinal fluid volumes and transit of dosage forms as assessed by magnetic resonance imaging

C Schiller et al.

ALIMENTARY PHARMACOLOGY & THERAPEUTICS (2005)

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Article Gastroenterology & Hepatology

Dual effects of rabeprazole on solid-phase gastric emptying assessed by the C-13-octanoate breath test

H Anjiki et al.

DIGESTION (2005)

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Article Chemistry, Medicinal

A physiological model for the estimation of the fraction dose absorbed in humans

S Willmann et al.

JOURNAL OF MEDICINAL CHEMISTRY (2004)

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Article Gastroenterology & Hepatology

Ambulatory 24-hour colonic manometry in slow-transit constipation

SSC Rao et al.

AMERICAN JOURNAL OF GASTROENTEROLOGY (2004)

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Article Chemistry, Multidisciplinary

Influence of the surface characteristics of PVM/MA nanoparticles on their bioadhesive properties

P Arbós et al.

JOURNAL OF CONTROLLED RELEASE (2003)

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Concentration-dependent effects of polyethylene glycol 400 on gastrointestinal transit and drug absorption

JDR Schulze et al.

PHARMACEUTICAL RESEARCH (2003)

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Article Pharmacology & Pharmacy

Predicting the impact of physiological and biochemical processes on oral drug bioavailability

B Agoram et al.

ADVANCED DRUG DELIVERY REVIEWS (2001)

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Article Chemistry, Multidisciplinary

The effect of polyethylene glycol 400 on gastrointestinal transit: Implications for the formulation of poorly-water soluble drugs

AW Basit et al.

PHARMACEUTICAL RESEARCH (2001)

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