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Volumn 46, Issue 8, 2008, Pages 415-420

Reliability of Japanese clinical trials estimated from GCP audit findings

Author keywords

Good Clinical Practice research environment; Japanese clinical trials

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; DRUG RESEARCH; GOOD CLINICAL PRACTICE; JAPAN; MEDICAL AUDIT; PRIVATE HOSPITAL; PROFESSIONAL STANDARDS REVIEW ORGANIZATION; PUBLIC HOSPITAL; RELIABILITY; UNIVERSITY HOSPITAL;

EID: 48749105647     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP46415     Document Type: Article
Times cited : (9)

References (14)
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    • Kusuoka H. Present status of CRC in Japan: a survey towards the globalization of clinical trial - international symposium on clinical research of new drugs. In: International Symposium on Clinical Research secretariat (ed). Record of International Symposium on Clinical Research. Tokyo: MIX, Elsevier; 2001. p. 28-41.
  • 4
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    • Ministry of Health, Labor and Welfare. Guideline for good clinical practice. Pharmaceutical Affairs Bureau Notification No. 874. Tokyo: Ministry of Health, Labor and Welfare; 1989.
    • Ministry of Health, Labor and Welfare. Guideline for good clinical practice. Pharmaceutical Affairs Bureau Notification No. 874. Tokyo: Ministry of Health, Labor and Welfare; 1989.
  • 5
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    • (1997) MHLW Ordinance , pp. 28
  • 6
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    • (2006) MHLW Ordinance , pp. 72
  • 7
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    • The quality of conduct in Japanese clinical trials: Deficiencies found in GCP inspections
    • Ono S, Kodama Y, Nagao T, Toyoshima S. The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections. Contr Clin Trials. 2002; 23: 29-41.
    • (2002) Contr Clin Trials , vol.23 , pp. 29-41
    • Ono, S.1    Kodama, Y.2    Nagao, T.3    Toyoshima, S.4
  • 8
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    • Recent changes in quality in Japanese clinical trials
    • Saito K, Kodama Y, Ono S, Fujimura A. Recent changes in quality in Japanese clinical trials. Ann Pharmacother. 2004; 38: 151-155.
    • (2004) Ann Pharmacother , vol.38 , pp. 151-155
    • Saito, K.1    Kodama, Y.2    Ono, S.3    Fujimura, A.4
  • 10
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    • Quality of Japanese clinical trials estimated from GCP audit findings
    • Saito K, Kodama Y, Ono S, Mutoh M, Kawashima S, Fujimura A. Quality of Japanese clinical trials estimated from GCP audit findings. Am J Ther. 2006a; 13: 127-133.
    • (2006) Am J Ther , vol.13 , pp. 127-133
    • Saito, K.1    Kodama, Y.2    Ono, S.3    Mutoh, M.4    Kawashima, S.5    Fujimura, A.6
  • 11
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    • Estimation of the quality of clinical trials from GCP audit findings in Japan
    • Saito K, Kodama Y, Ono S, Maida C, Mutoh M, Miyamoto E. Estimation of the quality of clinical trials from GCP audit findings in Japan. Int J Pharm Med. 2006b; 20: 115-119.
    • (2006) Int J Pharm Med , vol.20 , pp. 115-119
    • Saito, K.1    Kodama, Y.2    Ono, S.3    Maida, C.4    Mutoh, M.5    Miyamoto, E.6
  • 14
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    • A survey of investigator's motivation to conducting clinical trials
    • Takeuchi M, Lagakos SW eds, Program and Abstract;
    • Uno H. A survey of investigator's motivation to conducting clinical trials. In: Takeuchi M, Lagakos SW (eds). The 7th Kitasato University-Harvard School of Public Health Symposium, Program and Abstract; 2006. p. 31-32.
    • (2006) The 7th Kitasato University-Harvard School of Public Health Symposium , pp. 31-32
    • Uno, H.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.