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. 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

X Zhang  1 , J Duan  2 , F Kesisoglou  3 , J Novakovic  4 , G L Amidon  5 , M Jamei  6 , V Lukacova  7 , T Eissing  8 , E Tsakalozou  1 , L Zhao  1 , R Lionberger  1
Affiliations

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

X Zhang et al. CPT Pharmacometrics Syst Pharmacol. 2017 Aug.

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.

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References

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