Biostatistical methodology in carcinogenicity studies

Research output: Contribution to journal › Article › Research › peer review

Authors

  • William R. Fairweather
  • Amit Bhattacharyya
  • Peter P. Ceuppens
  • Guenter Heimann
  • Ludwig A. Hothorn
  • Ralph L. Kodell
  • Karl K. Lin
  • Harry Mager
  • Brian J. Middleton
  • Wout Slob
  • Keith A. Soper
  • Nigel Stallard
  • John Ventre
  • Jane Wright

Research Organisations

External Research Organisations

  • U.S. Food and Drug Administration
  • GlaxoSmithKline GmbH and Co. KG
  • AstraZeneca
  • National Institute of Public Health and the Environment
  • Merck & Co., Inc.
  • University of Reading
  • Nycomed S.C.A. SICAR
  • IQVIA United Kingdom
  • Bayer Pharma AG
  • Bayer AG
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Details

Original languageEnglish
Pages (from-to)401-421
Number of pages21
JournalTherapeutic Innovation & Regulatory Science
Volume32
Issue number2
Publication statusPublished - 30 Dec 1998

Abstract

This paper addresses the design, conduct, and statistical analysis of carcinogenicity studies, especially in the context of drug products for human use. It contains suggestions concerning the choice of dose levels, number of animals, methods of slide reading, and the ensuing statistical analysis, focusing on the significance testing approach. The purpose of this document is to describe the current thinking of statisticians and others who work in the area of carcinogenicity studies. The authors represent experience gained in the pharmaceutical industry, regulatory agencies, and academia.

Keywords

    Carcinogenicity, Data analysis, Literature, Study design, Test statistics

ASJC Scopus subject areas

Sustainable Development Goals

Cite this

Biostatistical methodology in carcinogenicity studies. / Fairweather, William R.; Bhattacharyya, Amit; Ceuppens, Peter P. et al.
In: Therapeutic Innovation & Regulatory Science, Vol. 32, No. 2, 30.12.1998, p. 401-421.

Research output: Contribution to journal › Article › Research › peer review

Fairweather, WR, Bhattacharyya, A, Ceuppens, PP, Heimann, G, Hothorn, LA, Kodell, RL, Lin, KK, Mager, H, Middleton, BJ, Slob, W, Soper, KA, Stallard, N, Ventre, J & Wright, J 1998, 'Biostatistical methodology in carcinogenicity studies', Therapeutic Innovation & Regulatory Science, vol. 32, no. 2, pp. 401-421. https://doi.org/10.1177/009286159803200212, https://doi.org/10.15488/2987
Fairweather, W. R., Bhattacharyya, A., Ceuppens, P. P., Heimann, G., Hothorn, L. A., Kodell, R. L., Lin, K. K., Mager, H., Middleton, B. J., Slob, W., Soper, K. A., Stallard, N., Ventre, J., & Wright, J. (1998). Biostatistical methodology in carcinogenicity studies. Therapeutic Innovation & Regulatory Science, 32(2), 401-421. https://doi.org/10.1177/009286159803200212, https://doi.org/10.15488/2987
Fairweather WR, Bhattacharyya A, Ceuppens PP, Heimann G, Hothorn LA, Kodell RL et al. Biostatistical methodology in carcinogenicity studies. Therapeutic Innovation & Regulatory Science. 1998 Dec 30;32(2):401-421. doi: 10.1177/009286159803200212, 10.15488/2987
Fairweather, William R. ; Bhattacharyya, Amit ; Ceuppens, Peter P. et al. / Biostatistical methodology in carcinogenicity studies. In: Therapeutic Innovation & Regulatory Science. 1998 ; Vol. 32, No. 2. pp. 401-421.
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