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Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug Administration (FDA) and the Center for Research...

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Detalles Bibliográficos
Autores principales:	Wu, Fang, Mousa, Youssef, Raines, Kimberly, Bode, Chris, Tsang, Yu Chung, Cristofoletti, Rodrigo, Zhang, Hongling, Heimbach, Tycho, Fang, Lanyan, Kesisoglou, Filippos, Mitra, Amitava, Polli, James, Kim, Myong‐Jin, Fan, Jianghong, Zolnik, Banu S., Sun, Duxin, Zhang, Yi, Zhao, Liang
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2023
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196428/ https://www.ncbi.nlm.nih.gov/pubmed/36530026 http://dx.doi.org/10.1002/psp4.12907

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