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

On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches.” The overall aims of the workshop in...

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Detalles Bibliográficos
Autores principales: Babiskin, Andrew, Wu, Fang, Mousa, Youssef, Tan, Ming‐Liang, Tsakalozou, Eleftheria, Walenga, Ross L., Yoon, Miyoung, Raney, Sam G., Polli, James E., Schwendeman, Anna, Krishnan, Vishalakshi, Fang, Lanyan, 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/PMC10196436/
https://www.ncbi.nlm.nih.gov/pubmed/36631942
http://dx.doi.org/10.1002/psp4.12920

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196436/
https://www.ncbi.nlm.nih.gov/pubmed/36631942
http://dx.doi.org/10.1002/psp4.12920

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