Vol.33, No.2, Apr. 2006 Kyoritsu University of Pharmacy International Symposium:
Position and role of the Asian and Oceanic regions in drug development
   
contents
 
●EditorialKurihara M284-5
 
Kyoritsu University of Pharmacy International Symposium:
 Position and Role of the Asian and Oceanic Regions in Drug Development
  
  Opening remarkMochizuki M288-9
  Outcome of ICH and new drug evaluation in JapanToyoshima S291-308
  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 W309-25
   Clinical drug evaluation in Korea−Today and tomorrow−Lee D327-44
   Clinical development in China and East AsiaBishop A345-55
  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 N357-70
   Clinical studies in Asia at present and in futureYamamoto M371-85
  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 T387-92
   Ethnic differences in the response to anticancer agents frequently occurred in
    East Asia population
Sugimoto Y393-8
   Globalization of new drug development
    −from ICH to worldwide simultaneous development−
Suwa T,Yamazaki T399-414
  EpilogSuwa T,Yamazaki T415-8
 
●Material  
  Guidance on Central IRB by FDA: Explanatory overviewKurihara C421-3
  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 gameKawasaki T447-53
  Medical tourism: Crossing over the borderSaio T455-9
  Serious accident in phase one drug trial. Possible use of phase zero drug trial
  in drug development
Nakajima A461-2
 
Instructions for authors [English] 463
 
●Editor's noteNakajima A469


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