메뉴 건너뛰기




Volumn 17, Issue 15-16, 1998, Pages 1663-1673

Statistical shortcomings in licensing applications

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFERENCE PAPER; DRUG DEVELOPMENT; LICENSING; STATISTICAL ANALYSIS;

EID: 0032529142     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1663::aid-sim969>3.0.co;2-u     Document Type: Conference Paper
Times cited : (4)

References (24)
  • 1
    • 3543000550 scopus 로고    scopus 로고
    • Statisticians in the Pharmaceutical Industry, Macclesfield, revised
    • PSI Professional Standards Working Party. PSI Guideline Standard Operating Procedures, Statisticians in the Pharmaceutical Industry, Macclesfield, revised, 1996.
    • (1996) PSI Guideline Standard Operating Procedures
  • 2
    • 0029164844 scopus 로고
    • Biostatistical methodology in clinical trials - A European guideline
    • Lewis, J. A., Jones, D. R. and Röhmel, J. 'Biostatistical methodology in clinical trials - a European guideline', Statistics in Medicine, 14, 1655-1682 (1995).
    • (1995) Statistics in Medicine , vol.14 , pp. 1655-1682
    • Lewis, J.A.1    Jones, D.R.2    Röhmel, J.3
  • 4
    • 0003616470 scopus 로고
    • MHW Pharmaceutical Affairs Bureau, Tokyo, Japan, in Japanese
    • Ministry of Health and Welfare. Guideline for the Statistical Analysis of Clinical Trials, MHW Pharmaceutical Affairs Bureau, Tokyo, Japan, 1992, (in Japanese).
    • (1992) Guideline for the Statistical Analysis of Clinical Trials
  • 5
    • 0029069733 scopus 로고
    • Registration of drugs for treating cancer and HIV infection: A plea to carry out phase 3 trials before admission to the market
    • Koopmans, P. P. 'Registration of drugs for treating cancer and HIV infection: a plea to carry out phase 3 trials before admission to the market', British Medical Journal, 310, 1305-1306 (1995).
    • (1995) British Medical Journal , vol.310 , pp. 1305-1306
    • Koopmans, P.P.1
  • 7
    • 3543016199 scopus 로고    scopus 로고
    • MCA EuroDirect Publication, Medicines Control Agency, London, U.K.
    • Commission of the European Communities. Explanatory Note on Expert Reports in the Application Dossier, MCA EuroDirect Publication, Medicines Control Agency, London, U.K., 1996.
    • (1996) Explanatory Note on Expert Reports in the Application Dossier
  • 8
    • 0039562114 scopus 로고    scopus 로고
    • Mad Cows and ecstasy: Chance and choice in an evidence-based society
    • Smith, A. F. M. 'Mad Cows and ecstasy: chance and choice in an evidence-based society', Journal of the Royal Statistical Society, Series A, 159, 367-383 (1996).
    • (1996) Journal of the Royal Statistical Society, Series A , vol.159 , pp. 367-383
    • Smith, A.F.M.1
  • 10
  • 11
    • 0024583836 scopus 로고
    • Covariate imbalance and random allocation in clinical trials
    • Senn, S. J. 'Covariate imbalance and random allocation in clinical trials', Statistics in Medicine, 8, 467-475 (1989).
    • (1989) Statistics in Medicine , vol.8 , pp. 467-475
    • Senn, S.J.1
  • 12
    • 0026646767 scopus 로고
    • Meta-analysis in the regulation of medicines
    • Jones, D. R. and Lewis, J. A. 'Meta-analysis in the regulation of medicines', Pharamaceutical Medicine, 6, 193-205 (1992).
    • (1992) Pharamaceutical Medicine , vol.6 , pp. 193-205
    • Jones, D.R.1    Lewis, J.A.2
  • 14
    • 0026009636 scopus 로고
    • A general parametric approach to the meta-analysis of randomised clinical trials
    • Whitehead, A. and Whitehead, J. 'A general parametric approach to the meta-analysis of randomised clinical trials', Statistics in Medicine, 10, 1665-1677 (1991).
    • (1991) Statistics in Medicine , vol.10 , pp. 1665-1677
    • Whitehead, A.1    Whitehead, J.2
  • 16
    • 0032528855 scopus 로고    scopus 로고
    • Issues for covariance analysis of dichotomous and ordered categorical data from randomized clinical trials and non-parametric strategies for addressing them
    • Koch, G. G., Tangen, C. M., Jung, J.-W. and Amara, I. A. 'Issues for covariance analysis of dichotomous and ordered categorical data from randomized clinical trials and non-parametric strategies for addressing them', Statistics in Medicine, 17, 1863-1892 (1998).
    • (1998) Statistics in Medicine , vol.17 , pp. 1863-1892
    • Koch, G.G.1    Tangen, C.M.2    Jung, J.-W.3    Amara, I.A.4
  • 18
    • 0032528905 scopus 로고    scopus 로고
    • Counts and times to events
    • Lindsay, J. K. 'Counts and times to events', Statistics in Medicine, 17, 1745-1751 (1998).
    • (1998) Statistics in Medicine , vol.17 , pp. 1745-1751
    • Lindsay, J.K.1
  • 20
    • 0027955863 scopus 로고
    • Application of sample survey methods for modelling ratios to incidence densities
    • Lavange, L. M., Keyes, L. L., Koch, G. G. and Margolis, P. A. 'Application of sample survey methods for modelling ratios to incidence densities', Statistics in Medicine, 13, 343-355 (1994).
    • (1994) Statistics in Medicine , vol.13 , pp. 343-355
    • Lavange, L.M.1    Keyes, L.L.2    Koch, G.G.3    Margolis, P.A.4
  • 21
    • 0000968939 scopus 로고
    • On the combination of independent two sample tests of Wilcoxon
    • van Elteren, P. H., 'On the combination of independent two sample tests of Wilcoxon', Bulletin l'Institut de Statistique, 30, 351-361 (1960).
    • (1960) Bulletin l'Institut de Statistique , vol.30 , pp. 351-361
    • Van Elteren, P.H.1
  • 23
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones, B., Jarvis, P., Lewis, J. A. and Ebbutt, A. F. 'Trials to assess equivalence: the importance of rigorous methods', British Medical Journal, 313, 36-39 (1996).
    • (1996) British Medical Journal , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 24
    • 17144474198 scopus 로고    scopus 로고
    • The management of interim analyses in drug development
    • Facey, K. M. and Lewis, J. A. 'The management of interim analyses in drug development', Statistics in Medicine, 17, 1801-1809 (1998).
    • (1998) Statistics in Medicine , vol.17 , pp. 1801-1809
    • Facey, K.M.1    Lewis, J.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.