Considering Sex and Gender in Therapeutics throughout the Product Life Cycle: A Narrative Review and Case Study of Gilteritinib.

ABSTRACT:

Background

Biological sex-related factors influence pharmacokinetic, pharmacodynamic, and disease processes that may affect the predictability of drug dosing and adverse effects, which may in turn have clinical consequences for patients' lives. Nonetheless, sex-related factors are not always taken into account in clinical trial design or clinical decision-making, for multiple reasons, including a paucity of studies that clearly and objectively study and measure sex-disaggregated and sex-related outcomes, as well as gaps in regulatory and policy structures for integrating these considerations.

Objectives

To complete a narrative review and use a case study to understand available evidence, inform future research, and provide policy considerations that incorporate information o

SUBMITTER: Maximos M 

PROVIDER: S-EPMC10284287 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature