Ethnobridging In Phase I Clinical Trials

The potential for ethnicity to affect drug metabolism and distribution is well-known, with differences in safety, efficacy, labeled dosages, and/or adverse event profiles, fueling a belief that drug development should be geared to each geographic market. The ensuring seven to ten year drug approval lag in East Asia caused delated access, even for safe and effective drugs. As international regulatory bodies and the global pharmaceutical industry recognized the issue, multiregional clinical trials have become standardized, leading to quicker development times and increased valuations of your asset.