抄録
Recent breakthroughs in science and technology have the potential to transform our ability to prevent, diagnose and treat disease. Global clinical trials are expanding. A number of difficulties emerged in conducting global clinical trials in Japan. Ethnic factors in multinational clinical trials have been apparent to determine drug dosing. Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance. It is important to promote regulatory science for establishment of evidence-based medicine.
