Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.

Autor: Babiskin, Andrew1 (AUTHOR) andrew.babiskin@fda.hhs.gov, Wu, Fang1 (AUTHOR) fang.wu@fda.hhs.gov, Mousa, Youssef1 (AUTHOR), Tan, Ming‐Liang1 (AUTHOR), Tsakalozou, Eleftheria1 (AUTHOR), Walenga, Ross L.1 (AUTHOR), Yoon, Miyoung1 (AUTHOR), Raney, Sam G.2 (AUTHOR), Polli, James E.3 (AUTHOR), Schwendeman, Anna4 (AUTHOR), Krishnan, Vishalakshi4 (AUTHOR), Fang, Lanyan1 (AUTHOR), Zhao, Liang1 (AUTHOR)
Zdroj: CPT: Pharmacometrics & Systems Pharmacology. May2023, Vol. 12 Issue 5, p619-623. 5p.
Databáze: Academic Search Ultimate
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