Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?

ABSTRACT:

Background and objective

Mechanistic static and dynamic physiologically based pharmacokinetic models are used in clinical drug development to assess the risk of drug-drug interactions (DDIs). Currently, the use of mechanistic static models is restricted to screening DDI risk for an investigational drug, while dynamic physiologically based pharmacokinetic models are used for quantitative predictions of DDIs to support regulatory filing. As physiologically based pharmacokinetic model development by sponsors as well as a review of models by regulators require considerable resources, we explored the possibility of using mechanistic static models to support regulatory filing, using representative cases of successful physiologically based pharmacokinetic submissions to the US Food and Dr

SUBMITTER: Gomez-Mantilla JD 

PROVIDER: S-EPMC10042977 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature