Vol.30, No.2･3, Sep. 2003　Clinical research in the "Bio-Genome Century" and the revised Pharmaceutical Affairs Law
　 　
contents
 
●EditorialMitsuishi T228-30
 
●Clinical research in the "Bio-Genome Century" and the revised Pharmaceutical Affairs Law
 
・"Bio-Genome Century"−The social basis for regenerative medicine  
　 On the future of regenerative medicine of human cell：
　　　 Its philosophy, limitations and future opportunities		Nishikawa S，Fukushima M231-51
　 Infrastructure establishment for clinical evaluation of regenerative medicineChiba T253-5
　 Round table discussion：The conflict between medical and pharmaceutical
　　　 patenting and international health and bioethics		’tHoen EFM，Banta D，
Sumikura K，Mitsuishi T		257-72
　 Patenting the results of R&D and public policy objectivesTakagi Y273-80
 
・The revised Pharmaceutical Affairs Law and the clinical trial environment  
　 Round table discussion：
　　　 Perspectives for investigator-initiated registration trials at its starting point		Rinsho Hyoka Editorial Committee281-301
　 Clinical Research Center of University of Tokyo Hospital for the advancement of
　　　 clinical trials -Towards the highest quality and speedy conduct of clinical trials-		Arakawa Y，Omata M303-9
　 The actual status and perspective of the Shizuka Pharm-Valley InitiativeDoi H311-9
　 Current status of pediatric clinical trials：
　　　 Special focus on physician-initiated clinical trials for drug approval		Nakamura H321-7
 
●Topics  
　 Japan Medical Association's challenge for developing infrastructure of clinical trials
　　　 in the reformed regulatory situation
　　　 ─Interview with Hokuto Hoshi, Executive Board Member of JMA─		Hoshi H329-36
 
●Leading article  
　 Measuring the severity of diseases─Particularly in the field of psychiatryKurihara M，Suzuki Y337-51
 
●Review  
　 Sexual differences and the use of drugs −A review on clinical pharmacology−Shimizu N353-68
 
●Proposal  
　 Proposal of a Draft Human Research Participants Protection Bill：
　　　 As the most essential legal basis for bioethical issues		Mitsuishi T，Nudeshima J，
Kurihara C		369-95
 
●Material  
　 Report on the Developments of the Dutch System for Medical Ethical ReviewMarcel JH Kenter
（trans. by Uchida N，Uchida E）		397-405
 
●Forum  
　 On the evidence of EBM (continued)Yokota Y407-9
 
●Instructions for authors [English] 411-6
 
●Editor's noteTsutani K417


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