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Volumn 20, Issue 17-18, 2001, Pages 2549-2560

The impact of the international guideline entitled Statistical principles for clinical trials (ICH E9)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 0035884461     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.728     Document Type: Article
Times cited : (12)

References (14)
  • 1
    • 0033566652 scopus 로고    scopus 로고
    • Statistical Principles for Clinical Trails (ICH E9): An introductory note on an international guideline
    • (1999) Statistics in Medicine , vol.18 , pp. 1903-1904
    • Lewis, J.A.1
  • 2
    • 0033566769 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials
    • ICH E9 Expert Working Group.
    • (1999) Statistics in Medicine , vol.18 , pp. 1905-1942
  • 6
    • 0345320344 scopus 로고    scopus 로고
    • An issue of statistical analysis in controlled multicentre studies: How shall we weight the centres?
    • (1999) Statistics in Medicine , vol.18 , pp. 365-373
    • Lin, Z.1
  • 7
    • 0003634459 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products. Concept Papers on the development of a Committee for Proprietary Medicinal Products (CPMP) Points to Consider on biostatistical/methodological issues arising from on licensing applications. EMEA website
    • (1999)
  • 8
    • 0003637382 scopus 로고    scopus 로고
    • ICH Topic E10. Note for Guidance on Choice of Control Group in Clinical Trials. Step 2 Draft Consensus Guideline CPMP/ICH/364/96, The European Agency for the Evaluation of Medicines, London
    • (1999)
  • 9
    • 0003715759 scopus 로고    scopus 로고
    • U.S. Federal Register, 72, Number 39, 8963, February 27th
    • (1997)
  • 10
    • 0003712652 scopus 로고    scopus 로고
    • Ministry of Health and Welfare (MHW). Statistical principles for clinical trials (in Japanese).
    • (1998)
  • 11
    • 0003678185 scopus 로고    scopus 로고
    • ICH. Good Clinical Practice.
    • (1996)
  • 12
    • 0003629004 scopus 로고    scopus 로고
    • ICH. Ethnic Factors in the Acceptability of Foreign Clinical Data.
    • (1998)
  • 13
    • 0003728604 scopus 로고    scopus 로고
    • Trend of the number of clinical trials for license application in Japan (in Japanese)
    • (1999) Pharmacia , vol.35 , pp. 463-465
    • Nomura, Y.1
  • 14
    • 0033000708 scopus 로고    scopus 로고
    • Qualified statisticians in the European pharmaceutical industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) working group
    • EFSPI Working Group
    • (1999) Drug Information Journal , vol.33 , pp. 407-415


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.