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
View graph of relations

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, https://doi.org/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.
Download
@article{0d4b4223a09b45169414bd58b3ea8664,
title = "Biostatistical methodology in carcinogenicity studies",
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",
author = "Fairweather, {William R.} and Amit Bhattacharyya and Ceuppens, {Peter P.} and Guenter Heimann and Hothorn, {Ludwig A.} and Kodell, {Ralph L.} and Lin, {Karl K.} and Harry Mager and Middleton, {Brian J.} and Wout Slob and Soper, {Keith A.} and Nigel Stallard and John Ventre and Jane Wright",
year = "1998",
month = dec,
day = "30",
doi = "10.1177/009286159803200212",
language = "English",
volume = "32",
pages = "401--421",
journal = "Therapeutic Innovation & Regulatory Science",
issn = "2168-4790",
publisher = "SAGE Publications Inc.",
number = "2",

}

Download

TY - JOUR

T1 - Biostatistical methodology in carcinogenicity studies

AU - Fairweather, William R.

AU - Bhattacharyya, Amit

AU - Ceuppens, Peter P.

AU - Heimann, Guenter

AU - Hothorn, Ludwig A.

AU - Kodell, Ralph L.

AU - Lin, Karl K.

AU - Mager, Harry

AU - Middleton, Brian J.

AU - Slob, Wout

AU - Soper, Keith A.

AU - Stallard, Nigel

AU - Ventre, John

AU - Wright, Jane

PY - 1998/12/30

Y1 - 1998/12/30

N2 - 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.

AB - 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.

KW - Carcinogenicity

KW - Data analysis

KW - Literature

KW - Study design

KW - Test statistics

UR - http://www.scopus.com/inward/record.url?scp=84993728811&partnerID=8YFLogxK

U2 - 10.1177/009286159803200212

DO - 10.1177/009286159803200212

M3 - Article

AN - SCOPUS:84993728811

VL - 32

SP - 401

EP - 421

JO - Therapeutic Innovation & Regulatory Science

JF - Therapeutic Innovation & Regulatory Science

SN - 2168-4790

IS - 2

ER -