ABSTRACT
In recent years, the possible in©uence of ethnic factors on clinical outcomes for evaluating the ef‚cacy and safety of study medications under investigation has attracted much attention from both the pharmaceutical/biotechnology industry and regulatory agencies such as the U.S. Food and Drug Administration (FDA), especially when the sponsor is interested in bringing an approved drug product from the original region, such as the United States or the European Union, to a new region such as the Asia-Paci‚c region. As indicated in Caraco (2004), genetic determinants may mediate variability among persons in the response to a drug, which implies that patient response to therapeutics may vary from one racial/ethnic group to another. Some ethnic groups may exhibit clinically signi‚cant side effects, whereas others may have no therapeutic responses. Other ethnic factors that can distinguish new and original regions may include the social and cultural aspects of a region such as medical practice (e.g., diagnostic criteria), epidemiological difference (e.g., diet, tobacco or alcohol use, exposure to pollution and sunshine), and compliance with prescribed medications. As a result, the dose and dose regimen approved in the original region may not be appropriate (for achieving the desired therapeutic effect) for patients in a new region. Thus, it is important to demonstrate that the approved treatment at the original region will achieve similar or equivalent therapeutic effects (in terms of ef‚cacy and safety) when applied to patients in the new region before it can be approved and used there. However, it should be noted that if there is evidence of therapeutic differences due to race or ethnicity, the dose and dose regimen of the
test treatment is necessarily modi‚ed to achieve similar therapeutic effect as observed in the original region.
