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

Abstract 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 com...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Ine Skottheim Rusten, Flora Tshinanu Musuamba
Formato: article
Lenguaje:EN
Publicado: Wiley 2021
Materias:
Acceso en línea:https://doaj.org/article/22f9226774ba4d07af13a0fb0501d239
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!

Ejemplares similares