Vol.34, No.3, May 2007 Safety information: reporting, dissemination, and analysis
   
contents
 
●EditorialKageyama S390
 
●Safety information: reporting, dissemination, and analysis  
  Issues on safety information management in JapanKobayashi F,Tamura N391-7
  Handling of safety information during clinical trials with reference
   to ICH guidance and CIOMS recommendations
E. Stewart Geary399-408
 (trans. by Nakatsuka M,Boyar E,
Pharmacovigilance Working Group)
409-17
  The PAC (: Professional assessment of causality on ADR reports)
   Survey Study on DLST in 71,668 cases in Japan
Shimizu N,Koshikawa S,
Nomura T,et al.
419-26
  Why are Japanese boys dropping down?: Considerations on the
   cause of oseltamivir-related abnormal behavior
Saio T427-33
 
●The 2nd Kyoto University pharmacoepidemiology symposium  
   −The role of pharmacoepidemiology in the research and development of new drug−
     Organized by Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health,
    Kyoto University,Supervised by: Kawakami K
435-537
 
●Proposals and study reports  
  Where are we now in the race for innovation?−A proposal of
   three laws for stronger Japan
Fukushima M539-44
  Problems regarding the investigational products supply in J-GCP:
   To promote the global clinical trials
Ono M545-54
  Coordination report from a post-marketing study carried by a
   single organization: From the Prevention of Coronary Sclerosis
   (PCS) study
Uehara Y,Mizuno D,
Komatsu M,et al.
555-70
  Basis for the conduct of microdosing clinical trials in Japan:
   Third report Draft guidance for exploratory investigational new
   drug clinical trials
Sugiyama Y,Mayahara H,
Ikeda T,et al.
571-94
  Proposal of a Draft Human Research Participants Protection Bill 2007
   −The most essential legal basis for bioethical issues: Second report−
Mitsuishi T,Nudeshima J,
Kurihara C,et al.
595-611
 
●Forum  
  How do we translate "should" and "shall" into Japanese?Uchida E,Kageyama S,
Tsubaki H
613-4
  Mitsukoshi Radish Project (MDP), otherwise, Project KFD
   (Kentucky Fried Data)−Hey! Boys and Girls in Research Lab.
   How about CRO package service from non-clinical to clinical trial?−
Itoh K614-8
 
Instructions for authors [English] 619-24
 
●Editor's noteNudeshima J625



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