Open AccessMechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
Author(s) -
Zhang X,
Duan J,
Kesisoglou F,
Novakovic J,
Amidon GL,
Jamei M,
Lukacova V,
Eissing T,
Tsakalozou E,
Zhao L,
Lionberger R
Publication year - 2017
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12204
Subject(s) - bioequivalence , physiologically based pharmacokinetic modelling , absorption (acoustics) , food and drug administration , pharmacokinetics , dissolution testing , drug , bioavailability , biochemical engineering , pharmacology , computer science , management science , medicine , engineering , materials science , biopharmaceutics classification system , composite material
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.”[1][, 2016] 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.[2][Zhang, X., 2014]