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CPT Pharmacometrics Syst Pharmacol. 2017 Aug;6(8):492-495. doi: 10.1002/psp4.12204. Epub 2017 Jul 11.

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

Author information

1
Office of Research and Standards, Office of Generic Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA.
2
Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, Maryland, USA.
3
Biopharmaceutics and Specialty Dosage Forms, Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania, USA.
4
Apotex Inc, Toronto, Ontario, Canada.
5
Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.
6
Simcyp Limited (A Certara Company), Blades Enterprise Centre, Sheffield, UK.
7
Simulations Plus, Inc., Lancaster, California, USA.
8
Bayer AG, Systems Pharmacology, Leverkusen, Germany.

Abstract

On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework.

PMID:
28571121
PMCID:
PMC5572334
DOI:
10.1002/psp4.12204
[Indexed for MEDLINE]
Free PMC Article

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