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...

Descripción completa

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

Internet

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

Ejemplares similares