Biostatistical methodology in carcinogenicity studies

Publikation: Beitrag in Fachzeitschrift › Artikel › Forschung › Peer-Review

Autoren

  • 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

Organisationseinheiten

Externe Organisationen

  • U.S. Food and Drug Administration
  • GlaxoSmithKline GmbH and Co. KG (GSK)
  • 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
Forschungs-netzwerk anzeigen

Details

OriginalspracheEnglisch
Seiten (von - bis)401-421
Seitenumfang21
FachzeitschriftTherapeutic Innovation & Regulatory Science
Jahrgang32
Ausgabenummer2
PublikationsstatusVeröffentlicht - 30 Dez. 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.

ASJC Scopus Sachgebiete

Ziele für nachhaltige Entwicklung

Zitieren

Biostatistical methodology in carcinogenicity studies. / Fairweather, William R.; Bhattacharyya, Amit; Ceuppens, Peter P. et al.
in: Therapeutic Innovation & Regulatory Science, Jahrgang 32, Nr. 2, 30.12.1998, S. 401-421.

Publikation: Beitrag in Fachzeitschrift › Artikel › Forschung › 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, Jg. 32, Nr. 2, S. 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 Dez 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 ; Jahrgang 32, Nr. 2. S. 401-421.
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