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

Physiologically Based Absorption Modelling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Entrectinib

(2020) Neil Parrott et al.   AAPS Journal

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

Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions

(2020) Dorota Danielak et al.   AAPS PHARMSCITECH

Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective

(2020) Arian Emami Riedmaier et al.   AAPS Journal

In Vitro Biopredictive Methods: A Workshop Summary Report

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

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

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

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

(2019) Tycho Heimbach et al.   AAPS Journal

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

(2019) Amitava Mitra et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2018) Andreas Abend et al.   AAPS Journal

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

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

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

(2016) Lawrence X. Yu et al.   AAPS Journal

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

(2016) Sandra Suarez-Sharp 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

Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies

(2016) Filippos Kesisoglou et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2015) Filippos Kesisoglou et al.   AAPS Journal

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

(2015) HM Jones et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: In vitro, in vivo and in silico assessments

(2015) Joseph P. O’Shea et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Predicting the Effect of Cytochrome P450 Inhibitors on Substrate Drugs: Analysis of Physiologically Based Pharmacokinetic Modeling Submissions to the US Food and Drug Administration

(2014) Christian Wagner et al.   CLINICAL PHARMACOKINETICS

Modeling and Simulation of Biopharmaceutical Performance

(2014) X Zhang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

pH-Dependent Drug–Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development

(2014) L Zhang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

In vivo predictive mini-scale dissolution for weak bases: Advantages of pH-shift in combination with an absorptive compartment

(2014) Kerstin J. Frank et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Predicting Nonlinear Pharmacokinetics of Omeprazole Enantiomers and Racemic Drug Using Physiologically Based Pharmacokinetic Modeling and Simulation: Application to Predict Drug/Genetic Interactions

(2014) Fang Wu et al.   PHARMACEUTICAL RESEARCH

Utility of Physiologically Based Modeling and Preclinical In Vitro/In Vivo Data to Mitigate Positive Food Effect in a BCS Class 2 Compound

(2013) Binfeng Xia et al.   AAPS PHARMSCITECH

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Coupling biorelevant dissolution methods with physiologically based pharmacokinetic modelling to forecast in-vivo performance of solid oral dosage forms

(2013) Keiichi Otsuka et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

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

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

(2011) Xinyuan Zhang et al.   AAPS Journal

The Use of Biorelevant Dissolution Media to Forecast the In Vivo Performance of a Drug

(2010) Sandra Klein   AAPS Journal

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

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

Predicting in vivo absorption behavior of oral modified release dosage forms containing pH-dependent poorly soluble drugs using a novel pH-adjusted biphasic in vitro dissolution test

(2010) Ulrich Heigoldt et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS