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

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...

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Bibliographic Details
Published inCPT: pharmacometrics and systems pharmacology Vol. 6; no. 8; pp. 492 - 495
Main Authors Zhang, X, Duan, J, Kesisoglou, F, Novakovic, J, Amidon, GL, Jamei, M, Lukacova, V, Eissing, T, Tsakalozou, E, Zhao, L, Lionberger, R
Format Journal Article
LanguageEnglish
Published United States John Wiley & Sons, Inc 01.08.2017
John Wiley and Sons Inc
Subjects
Administration, Oral
Chemistry, Pharmaceutical
Computer Simulation
FDA approval
Food
Generic drugs
Humans
Models, Theoretical
Particle size
Pharmaceutical Preparations - administration & dosage
Product development
Simulation
Therapeutic Equivalency
United States
United States Food and Drug Administration
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Summary: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.
ISSN:2163-8306
2163-8306
DOI:10.1002/psp4.12204