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- W2008285675 abstract "Statistics in MedicineVolume 18, Issue 15 p. 1903-1942 Research Article Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline John A. Lewis, Corresponding Author John A. Lewis Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, U.K.Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, U.K.Search for more papers by this author John A. Lewis, Corresponding Author John A. Lewis Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, U.K.Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ, U.K.Search for more papers by this author First published: 03 August 1999 https://doi.org/10.1002/(SICI)1097-0258(19990815)18:15<1903::AID-SIM188>3.0.CO;2-FCitations: 177AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat REFERENCES 1 P. F. D'Arcy and D. W. G. Harron (eds), Proceedings of the First International Conference on Harmonisation, Queen's University of Belfast, 1992. 2 Lewis, J. A., Jones, D. R. and Röhmel, J. ‘Biostatistical methodology in clinical trials - a European guideline’, Statistics in Medicine, 14, 1655–1658 (1995).Medline 3 CPMP Working Party on Efficacy of Medicinal Products, ‘Biostatistical methodology in clinical trials in applications for marketing authorisations for medicinal products’, Statistics in Medicine, 14, 1659–1682 (1995).Medline 4 Food and Drug Administration, Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications, FDA, U.S. Department of Health and Human Services, Rockville, MA, U.S.A., 1988. 5 Ministry of Health and Welfare, Guideline for the Statistical Analysis of Clinical Trials, MHW Pharmaceutical Affairs Bureau, Tokyo, Japan, 1992 (in Japanese). 6 ‘ ICH Topic E3: Structure and content of clinical study reports’, MCA EuroDirect Publication No. 137/95, EuroDirect Publications Office, London, 1995. Citing Literature Volume18, Issue1515 August 1999Pages 1903-1942 ReferencesRelatedInformation" @default.
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