Science-Based Ethnic Bridging in Drug Development; Review of Recent Precedence and Suggested Steps Forward.

CONCLUSIONS: Recent precedence reflected a pragmatic, descriptive approach of racial or ethnic bridging, apparently meeting current regulatory expectations, whilst not resulting in strict guidance to prescribers. Next steps: We recommend further work on defining the objectives of bridging studies, as well as criteria for their design and data analysis. Regarding the latter we recommend investigating the value of prospectively defined tests for similarity with appropriate follow-up analysis in the case where the test has failed. PMID: 30961506 [PubMed - as supplied by publisher]
Source: Current Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Curr Clin Pharmacol Source Type: research