Shortening Drug Development Timelines with Asian Ethnobridging Trials

This guide discusses the strategy of Asian ethnobridging trials in drug development, particularly focusing on the need to adapt Phase I studies for the Asian market. It outlines how these trials can demonstrate biosimilarity between drug products for Asian and non-Asian populations by comparing pharmacokinetics across different ethnic groups. The document explains that conducting ethnobridging studies locally can significantly reduce drug development timelines, allowing for the recruitment of patients in global safety and efficacy trials without the need to repeat Phase I studies. The guide also details the intrinsic and extrinsic factors affecting drug metabolism in Asian populations, including genetic profiles and environmental influences. Additionally, it highlights the International Council for Harmonisation's ICH E5 and E17 guidelines, which provide frameworks for bridging data and conducting multi-regional clinical trials to expedite drug approval processes. The document emphasizes the importance of understanding regional requirements and the potential for earlier access to new drugs worldwide.