Description

I. Problems in the Acceptability of Foreign Clinical Data for Pharmaceuticals.- 1 Acceptability of foreign data: genetic, cultural and environmental differences - do they matter?.- 2 Genetic polymorphisms in drug metabolism: clinical implications and consequences in ADME studies.- 3 Inter-ethnic differences in dose-response studies.- 4 Evaluation methods for clinical trials of drugs in Japan which may affect ethnic differences.- 5 The top 50 drugs in the UK and Japan: why are they so different?.- 6 Ethnic differences in response to pharmaceuticals across Europe.- 7 Medical practice differences between Europe, the United States and Japan.- 8 A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective.- 9 Current approaches to global drug development from a European perspective.- 10 Current approaches to global drug development from a Japanese perspective.- 11 Summary of Session I.- II. The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines.- 12 The acceptability of foreign data in the registration of new medicines - Health Protection Branch viewpoint.- 13 The acceptability of foreign data in the registration of new medicines.- 14 Ethnic effects on pharmacokinetic parameters.- 15 A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations.- 16 Current status of CMR survey on inter-ethnic differences in clinical responsiveness.- III. The Relevance of Inter-Ethnic Differences for Drug Development and Registration.- 17 Implications for the design and interpretation of Phase III clinical trials.- 18 Dose-utility relationships in diverse populations: ethnic, age, gender and cultural factors in efficacy and safety.- 19 General discussion and concluding remarks.- Appendix - Workshop participants.