●Editorial | Kurihara M | 284-5 |
●Kyoritsu University of Pharmacy International Symposium: Position and Role of the Asian and Oceanic Regions in Drug Development | ||
Opening remark | Mochizuki M | 288-9 |
Outcome of ICH and new drug evaluation in Japan | Toyoshima S | 291-308 |
Session 1: Drug development in East Asian and Oceanic regions−Topics from the regions | ||
Clinical drug development and evaluation in Australia−Today and tomorrow− | Hooper W | 309-25 |
Clinical drug evaluation in Korea−Today and tomorrow− | Lee D | 327-44 |
Clinical development in China and East Asia | Bishop A | 345-55 |
Session 2: Clinical drug evaluation in East Asia and Oceania by Japanese firms | ||
New drug development and clinical trials in Asia −from a Japanese pharmaceutical company's viewpoint− | Nishikawa N | 357-70 |
Clinical studies in Asia at present and in future | Yamamoto M | 371-85 |
Session 3: Panel discussion | ||
Performing clinical studies classifying human subjects based on genetic background −Concept applicable to drugs with narrow safety margin: No inter-ethnic difference?− | Kamataki T | 387-92 |
Ethnic differences in the response to anticancer agents frequently occurred in East Asia population | Sugimoto Y | 393-8 |
Globalization of new drug development −from ICH to worldwide simultaneous development− | Suwa T,Yamazaki T | 399-414 |
Epilog | Suwa T,Yamazaki T | 415-8 |
●Material | ||
Guidance on Central IRB by FDA: Explanatory overview | Kurihara C | 421-3 |
Guidance for industry Using a centralized IRB review process in multicenter clinical trials | Food and Drug Administration (trans. by Kurihara C,Saio T) | 425-33 |
●Forum | ||
Medical context of China and watch soccer game | Kawasaki T | 447-53 |
Medical tourism: Crossing over the border | Saio T | 455-9 |
Serious accident in phase one drug trial. Possible use of phase zero drug trial in drug development | Nakajima A | 461-2 |
●Instructions for authors [English] | 463 | |
●Editor's note | Nakajima A | 469 |