Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

(2023) Abdullah Al Shoyaib et al.   CPT-Pharmacometrics & Systems Pharmacology

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

(2022) Ross L. Walenga et al.   CPT-Pharmacometrics & Systems Pharmacology

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

(2022) Fang Wu et al.   CPT-Pharmacometrics & Systems Pharmacology

Mechanistic modeling of drug products applied to the skin: A workshop summary report

(2022) Eleftheria Tsakalozou et al.   CPT-Pharmacometrics & Systems Pharmacology

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

(2021) Fang Wu et al.   AAPS Journal

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

(2021) Fang Wu et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Research and Education Needs for Complex Generics

(2021) Sydney Stern et al.   PHARMACEUTICAL RESEARCH

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

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

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence

(2020) Jieon Lee et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2020) Amitava Mitra et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Innovation for Generic Drugs: Science and Research under GDUFA

(2019) Robert A. Lionberger   CLINICAL PHARMACOLOGY & THERAPEUTICS

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

(2019) Tycho Heimbach et al.   AAPS Journal

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

(2018) Bart Hens et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Food Effect Projections via Physiologically Based Pharmacokinetic Modeling: Predictive Case Studies

(2018) Christophe Tistaert et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Generating Model Integrated Evidence for Generic Drug Development and Assessment

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

Predicting the Effect of CYP3A Inducers on the Pharmacokinetics of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK Submissions to the US FDA

(2015) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS