Related Experiment Video
Updated: Jun 24, 2026

In Silico Modeling Method for Computational Aquatic Toxicology of Endocrine Disruptors: A Software-Based Approach Using QSAR Toolbox
Published on: August 28, 2019
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence
Abdullah Al Shoyaib1, Arian Emami Riedmaier2, Anita Kumar3
1Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, Silver Spring, USA.
Abstract:
This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches." The US Food and Drug Administration in collaboration with the Center for Research on Complex Generics organized this workshop where this particular session titled "Oral PBPK for Evaluating the Impact of Food on BE" presented successful cases of PBPK modeling approaches for food effect assessment. Recently, PBPK modeling has started to gain popularity among academia, industries, and regulatory agencies for its potential utility during bioavailability (BA) and/or bioequivalence (BE) studies of new and generic drug products to assess the impact of food on BA/BE. Considering the promises of PBPK modeling in generic drug development, the aim of this workshop session was to facilitate knowledge sharing among academia, industries, and regulatory agencies to understand the knowledge gap and guide the path forward. This report collects and summarizes the information presented and discussed during this session to disseminate the information into a broader audience for further advancement in this area.
Related Concept Videos
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal assumptions,...
Model Approaches for Pharmacokinetic Data: Physiological Models
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Measurement of Bioavailability: Pharmacodynamic Methods
Dosage Regimens: Partial Pharmacokinetic Parameters
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

