Shortening Drug Development Timelines With Asian Ethnobridging Trials

Developing drugs for the Asian market may require that Phase 1 studies be repeated in regions outside North America or Europe, to determine whether the pharmacokinetics of the investigational drug are equivalent in different ethnic groups. Asian ethnobridging is a strategy to demonstrate biosimilarity of drug products between Asian and non-Asian populations by comparing pharmacokinetics of the investigational drug in both ethnic groups, considering both intrinsic and extrinsic factors.

Conducting ethnobridging studies locally, during Phase 1, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase 1 ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases 2 and 3) without repeating Phase I development in that region and population.