Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

The use of computational models in drug development has grown during the past decade. These model‐informed drug development (MIDD) approaches can inform a variety of drug development and regulatory decisions. When used for regulatory decision making, it is important to establish that the model is cr...

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Detalles Bibliográficos
Autores principales: Kuemmel, Colleen, Yang, Yuching, Zhang, Xinyuan, Florian, Jeffry, Zhu, Hao, Tegenge, Million, Huang, Shiew‐Mei, Wang, Yaning, Morrison, Tina, Zineh, Issam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966181/
https://www.ncbi.nlm.nih.gov/pubmed/31652029
http://dx.doi.org/10.1002/psp4.12479

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966181/
https://www.ncbi.nlm.nih.gov/pubmed/31652029
http://dx.doi.org/10.1002/psp4.12479

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