Clinical studies/trials ethnic differences

Foreign clinical results are acceptable except in areas where there are immunological and ethnic differences between Japanese and foreigners. The ethnic factors are divided into two components intrinsic factors such as racial factors and physiological differences and extrinsic factors, which include cultural and environmental issues. In these cases, the MHLW may require that some bridging comparative clinical trials be performed with dose ranging protocols. This will enable absorption, distribution, metabolism, and excretion studies to be carried out on Japanese individuals and provide better dosage and indication for the Japanese people. The MHLW also requires that application be accompanied by one year of real-time stability data and that sterility test results be included. 

Phase III clinical studies are expanded, controlled, or uncontrolled trials on efficacy and safety in various clinical settings and under practical conditions. Altogether several hundred to several thousand trial subjects are enrolled at various trial sites, which are often distributed over several countries in order to study different epidemiological situations, ethnic populations, and deviating local medical practices. Phase III studies can also be evaluated for risk-benefit relationships and address practicability aspects as well as interactions by other products or concomitantly applied medical treatments. Postmarketing clinical trials of the licensed... 

Phase 11/111 clinical studies The PK/PD model(s) in population studies during Phase 11/111 will be tested to assess variation due to differences from genetics, demographics (age, sex, ethnicity, etc.), diet, smoking, alcohol intake, disease conditions, concomitant drugs, hepatic or renal insufficiency, and other altered metabolic conditions. Table 2.1 represents a list of some potential biomarkers used in the cliiucal trials. 

---