Global Studies in Asians May Be Applicable to a Wide Array of Asian Populations

Traditionally, the Japanese regulatory agency required that drug studies be performed specifically in Japanese people before a drug would be considered for approval in Japan; however, recent studies done in different Asian populations, including Japanese people, as well as studies done in different races have been used for regulatory approval in Asian populations when appropriate.

A new Journal of Clinical Pharmacology study shows how guidelines on the use of clinical data have resulted in more reliable data worldwide, allowing drugs to reach Asian populations sooner than in the past.