Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help

Generics 2030: Where Are We Heading in 2030 for Generic Drug Science, Research, and Regulation?

(2020) Lei Zhang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Duodenum Intestine-Chip for preclinical drug assessment in a human relevant model

(2020) Magdalena Kasendra et al.   eLife

Assessing the impact of cystic fibrosis on the antipyretic response of ibuprofen in children: Physiologically‐based modeling as a candle in the dark

(2020) Brian Cicali et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

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

(2020) Xavier J.H. Pepin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models

(2020) Dan Liu et al.   AAPS Journal

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

(2020) Lei Miao et al.   AAPS Journal

Human Microphysiological Models of Intestinal Tissue and Gut Microbiome

(2020) Steven N. Steinway et al.   Frontiers in Bioengineering and Biotechnology

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

(2020) Neil Parrott et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Inter‐individual and inter‐regional variations in enteric drug metabolizing enzyme activities: Results with cryopreserved human intestinal mucosal epithelia (CHIM) from the small intestines of 14 donors

(2020) Albert P. Li et al.   Pharmacology Research & Perspectives

Unraveling the behavior of oral drug products inside the human gastrointestinal tract using the aspiration technique: History, methodology and applications

(2020) Patrick Augustijns et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Innovation for Generic Drugs: Science and Research under GDUFA

(2019) Robert A. Lionberger   CLINICAL PHARMACOLOGY & THERAPEUTICS

Accounting for inter-correlation between enzyme abundance: a simulation study to assess implications on global sensitivity analysis within physiologically-based pharmacokinetics

(2019) Nicola Melillo et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?

(2019) Meera Shrivas et al.   Journal of Pharmaceutical Innovation

Development of Human in vitro Brain-blood Barrier Model from Induced Pluripotent Stem Cell-derived Endothelial Cells to Predict the in vivo Permeability of Drugs

(2019) Yuan Li et al.   Neuroscience Bulletin

Human intestinal spheroids cultured using Sacrificial Micromolding as a model system for studying drug transport

(2019) Karen E. Samy et al.   Scientific Reports

Integrating drug- and formulation-related properties with gastrointestinal tract variability using a product-specific particle size approach: case example ibuprofen

(2019) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2019) Ioannis Loisios-Konstantinidis et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Transporters in Drug Development: 2018 ITC Recommendations for Transporters of Emerging Clinical Importance

(2018) Maciej J. Zamek-Gliszczynski et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The International Transporter Consortium: Summarizing advances in the role of transporters in drug development

(2018) Kathleen M. Giacomini et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro , Imaging and Physiologically Based Pharmacokinetic Modeling Approaches

(2018) Yingying Guo et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Development of a primary human Small Intestine-on-a-Chip using biopsy-derived organoids

(2018) Magdalena Kasendra et al.   Scientific Reports

Adjustment of the area under the concentration curve by terminal rate constant for bioequivalence assessment in a parallel-group study of lamotrigine

(2018) Jiansong Yang et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Generating Model Integrated Evidence for Generic Drug Development and Assessment

(2018) Liang Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically based absorption modeling to predict bioequivalence of controlled release and immediate release oral products

(2018) Amitava Mitra et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

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

(2018) James Butler et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

(2017) Kosuke Doki et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole

(2017) Rodrigo Cristofoletti et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

(2017) Bart Hens et al.   MOLECULAR PHARMACEUTICS

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

(2017) Shriram M. Pathak et al.   MOLECULAR PHARMACEUTICS

Development of a Novel Simplified PBPK Absorption Model to Explain the Higher Relative Bioavailability of the OROS® Formulation of Oxybutynin

(2016) Andrés Olivares-Morales et al.   AAPS Journal

Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

(2016) Edwin Chiu Yuen Chow et al.   AAPS Journal

Examining the Use of a Mechanistic Model to Generate an In Vivo/In Vitro Correlation: Journey Through a Thought Process

(2016) Bipin Mistry et al.   AAPS Journal

Resolving the physiological conditions in bioavailability and bioequivalence studies: Comparison of fasted and fed state

(2016) Felix Schneider et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir

(2016) Soundarya Vaithianathan et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Translating Human Effective Jejunal Intestinal Permeability to Surface-Dependent Intrinsic Permeability: a Pragmatic Method for a More Mechanistic Prediction of Regional Oral Drug Absorption

(2015) Andrés Olivares-Morales et al.   AAPS Journal

Deconvolution and IVIVC: Exploring the Role of Rate-Limiting Conditions

(2015) Alison Margolskee et al.   AAPS Journal

Analysis of the impact of controlled release formulations on oral drug absorption, gut wall metabolism and relative bioavailability of CYP3A substrates using a physiologically-based pharmacokinetic model

(2015) Andrés Olivares-Morales et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation

(2015) Andrew H. Babiskin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Incorporation of stochastic variability in mechanistic population pharmacokinetic models: handling the physiological constraints using normal transformations

(2015) Nikolaos Tsamandouras et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products

(2015) Masahisa Sugihara et al.   MOLECULAR PHARMACEUTICS

The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

(2015) Alan Parr et al.   PHARMACEUTICAL RESEARCH

G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS

(2014) Vinod P. Shah et al.   AAPS Journal

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

(2012) Barbara M. Davit et al.   AAPS Journal

Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model

(2011) A. S. Darwich et al.   CURRENT DRUG METABOLISM

How Well Can the Caco-2/Madin−Darby Canine Kidney Models Predict Effective Human Jejunal Permeability?†

(2010) Alex Avdeef et al.   JOURNAL OF MEDICINAL CHEMISTRY

Membrane transporters in drug development

(2010)   NATURE REVIEWS DRUG DISCOVERY

PBPK modelling of inter-individual variability in the pharmacokinetics of environmental chemicals

(2010) Frédéric Y. Bois et al.   TOXICOLOGY

A Framework for Assessing Inter-individual Variability in Pharmacokinetics Using Virtual Human Populations and Integrating General Knowledge of Physical Chemistry, Biology, Anatomy, Physiology and Genetics: A Tale of ‘Bottom-Up’ vs ‘Top-Down’ Recognition of Covariates

(2009) Masoud Jamei et al.   Drug Metabolism and Pharmacokinetics

Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications

(2008) Barbara M. Davit et al.   AAPS Journal