Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

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

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

(2023) Andrew Babiskin et al.   CPT-Pharmacometrics & Systems Pharmacology

Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery

(2023) Miyoung Yoon et al.   CPT-Pharmacometrics & Systems Pharmacology

Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development

(2022) Mohamed-Eslam F. Mohamed et al.   AAPS Journal

Applications of PBPK/PBBM modeling in generic product development: An industry perspective

(2022) Yuvaneshwari K et al.   JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY

Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective

(2022) Wen Lin et al.   PHARMACEUTICAL RESEARCH

Investigating the Mechanisms behind the Positive Food Effect of Abiraterone Acetate: In Vitro and Rat In Situ Studies

(2022) Marlies Braeckmans et al.   Pharmaceutics

Modelling and Simulation Approaches to Support Formulation Optimization, Clinical Development and Regulatory Assessment of the Topically Applied Formulations– Nimesulide Solution Gel Case Study

(2022) Naresh Mittapelly et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

(2022) Sumit Arora et al.   MOLECULAR PHARMACEUTICS

Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs

(2022) Di Wu et al.   PHARMACEUTICAL RESEARCH

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

(2022) Nikunjkumar Patel et al.   CPT-Pharmacometrics & Systems Pharmacology

Intra- and inter-subject variability in gastric pH following a low-fat, low-calorie meal

(2022) Hala M. Fadda et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development

(2022) Di Wu et al.   PHARMACEUTICAL RESEARCH

A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products

(2022) J. F. Clarke et al.   Frontiers in 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

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

(2021) Eleftheria Tsakalozou et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

(2021) Tycho Heimbach et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

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

(2021) Marc Laisney et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

(2020) Maxime Le Merdy et al.   AAPS Journal

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

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

Model-Informed Drug Development: Current U.S. Regulatory Practice and Future Considerations

(2019) Yaning Wang et al.   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

The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

(2019) Mirko Koziolek et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Development of In Vitro–In Vivo Correlation for Upadacitinib Extended-Release Tablet Formulation

(2019) Mohamed-Eslam F. Mohamed et al.   AAPS Journal

Exposure–Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit–Risk Assessment in Rheumatoid Arthritis

(2019) Ahmed Nader et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

An Investigation into the Factors Governing Drug Absorption and Food Effect Prediction Based on Data Mining Methodology

(2019) Biljana Gatarić et al.   AAPS Journal

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives

(2019) Mark McAllister et al.   Pharmaceutics

Physiologically Based Absorption Modeling of Salts of Weak Bases Based on Data in Hypochlorhydric and Achlorhydric Biorelevant Media

(2018) Filippos Kesisoglou et al.   AAPS PHARMSCITECH

Food for thought: formulating away the food effect - a PEARRL review

(2018) Joseph P. O'Shea et al.   JOURNAL OF PHARMACY AND PHARMACOLOGY

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

(2018) Sandra Suarez-Sharp et al.   AAPS Journal

Identification of beagle food taking patterns and protocol for food effects evaluation on bioavailability

(2018) Guoqing Zhang et al.   Scientific Reports

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

(2016) Sandra Suarez-Sharp et al.   AAPS Journal

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

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