Biostatistical methodology in carcinogenicity studies

authored by

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

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.

Organisation(s)

Department of Biostatistics

External Organisation(s)

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

Type

Article

Journal

Therapeutic Innovation & Regulatory Science

Volume

32

Pages

401-421

No. of pages

21

ISSN

2168-4790

Publication date

30.12.1998

Publication status

Published

Peer reviewed

Yes

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Public Health, Environmental and Occupational Health, Pharmacology (medical)

Sustainable Development Goals

SDG 3 - Good Health and Well-being

Electronic version(s)

https://doi.org/10.1177/009286159803200212 (Access: Closed)
https://doi.org/10.15488/2987 (Access: Open)