Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence for Long‐Acting Injectable and Implantable (LA...

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Detalles Bibliográficos
Autores principales: Gong, Yuqing, Zhang, Peijue, Yoon, Miyoung, Zhu, Hao, Kohojkar, Ameya, Hooker, Andrew C., Ducharme, Murray P., Gobburu, Jogarao, Cellière, Géraldine, Gajjar, Parmesh, Li, Bing V., Velagapudi, Raja, Tsang, Yu Chung, Schwendeman, Anna, Polli, James, Fang, Lanyan, Lionberger, Robert, 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/PMC10196434/
https://www.ncbi.nlm.nih.gov/pubmed/36710372
http://dx.doi.org/10.1002/psp4.12931

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196434/
https://www.ncbi.nlm.nih.gov/pubmed/36710372
http://dx.doi.org/10.1002/psp4.12931

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