Can PBPK Modeling Streamline Food Effect Assessments?
Author:
Affiliation:
1. Biopharmaceutics Pharmaceutical Sciences, Merck & Co., Inc. Kenilworth New Jersey USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1678
Reference15 articles.
1. United States Food and Drug Administration.Clinical Drug Interaction Studies—Study Design Data Analysis and Clinical Implications Draft Guidance; October 2017.https://www.fda.gov/media/82734/download. Accessed April 28 2020.
2. Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance
3. Dissolution and translational modeling strategies toward establishing an in vitro‐in vivo link‐a workshop summary report;Heimbach T;AAPS J,2019
4. PBPK models for the prediction of in vivo performance of oral dosage forms
5. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies
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