Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework

Empirical pharmacometric models are part of practically every regulatory submission for a new drug. The use of the models often exceeds descriptory roles and this change in their context of use increase the requirements on the evidence to support that they are credible. However, when it comes to ass...

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Detalles Bibliográficos
Autores principales: Skottheim Rusten, Ine, Musuamba, Flora Tshinanu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592505/
https://www.ncbi.nlm.nih.gov/pubmed/34514745
http://dx.doi.org/10.1002/psp4.12708

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592505/
https://www.ncbi.nlm.nih.gov/pubmed/34514745
http://dx.doi.org/10.1002/psp4.12708

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