Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

Model-informed drug development (MIDD) is a powerful approach to support drug development and regulatory review. There is a rich history of MIDD applications at the U.S. Food and Drug Administration (FDA). MIDD applications span across the life cycle of the development of new drugs, generics, and bi...

Descripción completa

Detalles Bibliográficos
Autores principales: Madabushi, Rajanikanth, Seo, Paul, Zhao, Liang, Tegenge, Million, Zhu, Hao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Review Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097888/
https://www.ncbi.nlm.nih.gov/pubmed/35552984
http://dx.doi.org/10.1007/s11095-022-03288-w

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097888/
https://www.ncbi.nlm.nih.gov/pubmed/35552984
http://dx.doi.org/10.1007/s11095-022-03288-w

Ejemplares similares