Statistical methods for exploring spontaneous adverse event reporting databases for drug-host factor interactions.

ABSTRACT:

Background

Drug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to specific drug properties (i.e., drug-host interaction). This concept is crucial for personalized drug safety but remains under-studied, primarily due to methodological challenges and limited data availability. By monitoring a large volume of adverse event reports in the postmarket stage, spontaneous adverse event reporting systems provide an unparalleled resource of information for adverse events and could be utilized to explore risk disparities of specific adverse events by age, sex, and other host factors. However, well-formulated statistical methods to formally address such risk disparities are currently lacking.

Methods

In

SUBMITTER: Lu Z 

PROVIDER: S-EPMC10041785 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature