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

• Հիմնական հեղինակներ: Ine Skottheim Rusten (Հեղինակ), Flora Tshinanu Musuamba (Հեղինակ)
• Ձևաչափ: Գիրք
• Հրապարակվել է: Wiley, 2021-11-01T00:00:00Z.
• Խորագրեր: article
• Առցանց հասանելիություն: Connect to this object online.

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...