Vol.35, No.3, Jun. 2008 J-CLIPNET - Bases for early phase global clinical development
   
Contents
 
●EditorialOhashi K434
 
●J-CLIPNET−Bases for early phase global clinical development  
Reports  
  Early phase global clinical trial's infrastructure development:
   A report of the activity of J-CLIPNET
Ohashi K435-50
  Report of visiting program to Europe by J-CLIPNETOhashi K, Uchida E, Kumagai Y, et al.451-85
  Explanatory review on the documents for improvement of phase 1 clinical
   trials, published in the United Kingdom and in the European Union,
   translated into Japanese in this issue
Ohashi K, Kurihara C, Saio T487-97
 
Translations  
  Translated documents concerning phase 1 clinical trials by J-CLIPNET
    Medicines and Healthcare products Regulatory Agency(MHRA),
    European Medicines Agency(EMEA),
    The Association of the British Pharmaceutical Industry(ABPI)
(trans. by Ohashi K, Uchida E, Umemura K, et al.)499-592
 
●Articles  
  Survey results of clinical data management education in medical institutions
   in Japan
Kanda N, Uno H, Aotani E, Takahashi F593-607
  Survey for utilization of Electronic Data Capture in clinical trials conducted
   by pharmaceutical companies in Japan
Matsuba H, Yamamoto K, Teramukai S, Fukushima M609-24
  Paradoxical medicines:long-term administration of bisphosphonates evokes
   clinical bone-fracture
Saio T625-32
 
●Proposals  
  Draft guidance for exploratory investigational new drug clinical trials:
   Except microdosing
Sugiyama Y, Mayahara H, Ikeda T, et al.633-50
  Meaning and basis for the conduct of microdose clinical trials on peptides
   and proteins in Japan
Yano T, Sugiyama Y, Kato M, et al.651-65
  Actual status of GCP investigations and future perspective
   −For solution of "over quality issue":
   Focused on comparation of Japan, US, EU regulations−
Watanabe H, Kageyama S, Kurihara C667-81
  An opinion to the Expert Committee on the Ethical Guideline for Clinical
   Research(1):An explanatory speech on the public comment
   (September 13, 2007)
Mitsuishi T683-8
  An opinion to the Expert Committee on the Ethical Guideline for Clinical
   Research(2):Essential issues for the Ethical Guideline for Clinical
   Research:i.e. history of the Declaration of Helsinki, ethics committee,
   substituted judgment and research results publication(February 13, 2008)
Mitsuishi T689-98
 
●Forum  
  Why do we not think about an academic discount for microdosing study?Itoh K699-702
  Unmet medical demand:research and development of innovative medicinesSaio T703-4
 
Instructions for authors[Japanese]&[English] 705-10
 
●Editor's noteFukushima M711


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