Translatability of in vitro potency to clinical efficacious exposure: A retrospective analysis of FDA-approved targeted small molecule oncology drugs.

ABSTRACT: In vitro potency is one of the important parameters representing efficacy potential of drugs and commonly used as benchmark of efficacious exposure at early clinical development. There are limited numbers of studies which systematically investigate on how predictive in vitro potency is to estimate therapeutic drug exposure, especially those focusing on targeted anticancer agents despite the recent increase in approvals. This study aims to fill in such knowledge gaps. A total of 87 small molecule targeted drugs approved for oncology indication between 2001 and 2020 by the US Food and Drug Administration (FDA) were identified; relevant preclinical and clinical data were extracted from the public domain. Relationships between the in vitro potency and the therapeutic dose or exposure (unbound

SUBMITTER: Kotani N 

PROVIDER: S-EPMC10432864 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature