Findings on In Vitro Transporter-Mediated Drug Interactions and Their Follow-Up Actions for Labeling: Analysis of Drugs Approved by US FDA between 2017 and 2021.

ABSTRACT: Understanding possible follow-up actions on in vitro findings helps determine the necessity of labeling for drug interactions. We analyzed information for in vitro findings on transporter-mediated interactions of drugs approved by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research for the last five years (i.e., 2017-2021) and their follow-up actions for labeling. Higher R values than the pre-defined cut-off were observed with 3.7-39.1% inhibitor drugs in a simple prediction. Among these drugs, 16-41.7% were labeled with their potential drug interactions, while results of supporting studies or scientific rationales were submitted for the other drugs leading to no interaction labeling. In vitro transporter substrates were reported with 1.7-67.6% of drugs. The int

SUBMITTER: Lee KR 

PROVIDER: S-EPMC9607947 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature