New drug approval times and clinical evidence in Japan

Contemporary Clinical Trials

Volumn 26, Issue 6, 2005, Pages 660-672

  Ono, Shunsuke ^a,c   Yoshioka, Chisato ^a   Asaka, Orie ^b   Tamura, Koji ^b   Shibata, Taro ^c   Saito, Kazuyuki ^c  

^a KANAZAWA UNIVERSITY   (Japan)

^b Japan Pharmaceutical Manufacturers Association   (Japan)

^c PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Clinical evidence; Japan; New drug approval time; Review system

Indexed keywords

NEW DRUG;

ARTICLE; CLINICAL TRIAL; CONSULTATION; DRUG APPROVAL; JAPAN; QUALITY CONTROL; SAFETY; TIME;

DRUG APPROVAL; DRUG INDUSTRY; DRUG MONITORING; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; JAPAN; QUESTIONNAIRES; REGRESSION ANALYSIS; TIME FACTORS;

EID: 28344452694     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2005.07.003     Document Type: Article

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