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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer US
2022
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| Materias: | |
| 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 |