Biostatistical Methodology in Carcinogenicity Studies
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
BIOSTATISTICAL METHODOLOGY IN CARCINOGENICITY STUDIES* WILLIAMR. FAIRWEATHER, PHD Associate Director, Office of Epidemiology & Biostatistics, Center for Drug Evaluation & Research, Food & Drug Administration, Rockville, Maryland
AMITBHA~ACHARYYA, PHD Senior Statistician, SmithKline Beecham Pharmaceuticals R&D, Hertfordshire, United Kingdom
PETERP. CEUPPENS,PHD Zeneca Pharmaceuticals, United Kingdom
GUENTERHEIMANN,DR. RER.
NAT.
Corporate Biometry, Schering AG, Berlin, Germany
LUDWIGA. HOTHORN,PHD Professor, University of Hannover, Hannover, Germany
RALPHL. KODELL,PHD Division of Biometry & Risk Assessment, National Center for Toxicological Research, Food & Drug Administration, Jefferson, Arkansas
KARL K. LIN, PHD Division of Biometrics 11, Office of Epidemiology & Biostatistics, Center for Drug Evaluation & Research, Food & Drug Administration, Rockville, Maryland
HARRYMAGER,PHD Head, Preclinical and Clinical Biostatistics, Center of Drug Research, Biometry, Bayer AG, Wuppertal, Germany
BRIANJ. MIDDLETON Zeneca Pharmaceuticals, United Kingdom
WOUTSLOB,PHD National Institute for Public Health and Environment (RIVM), Bilthoven, The Netherlands
KEITHA. SOPER,PHD Senior Research Statistician, Merck Research Laboratories, West Point, Pennsylvania
NIGELSTALLARD, PHD Medical and Pharmaceutical Statistics Research Unit, University of Reading, Reading, United Kingdom
JOHNVENTRE,MS Nycomed, United States
JANEWRIGHT,PHD Quintiles, United Kingdom
Reprint address: William R. Fairweather. Associate Director, Offce of Epidemiology & Biostatistics, HFD-700, US Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. *The views expressed herein are those of the authors and not necessarily those of their employers. Downloaded from dij.sagepub.com at UNIV PRINCE EDWARD ISLAND on July 7, 2015
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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. Key Words: Carcinogenicity; Study design; Data analysis; Test statistics; Literature
INTRODUCTION THIS PAPER ADDRESSES the design, conduct, and statistical analysis of carcinogenicity studies, especially in the context of drug products for human use. In these studies laboratory animals are exposed to a chemical compound during a period of time (usually a large fraction of their lifespan), after which the animals are sacrificed and examined for the presence of tumors. These studies are intended to provide insight into the compound
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