CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data
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1998
0092-8615/98 Copyright 0 1998 Dmg Information Association Inc.
CDER/FDA FORMATS FOR SUBMISSION OF ANIMAL CARCINOGENICITY STUDY DATA* KARL K. LIN, PHD Expert Mathematical Statistician (Applications in Pharmacology/Toxicology), Division of Biometrics 11, Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
The Center for Drug Evaluation and ResearcWFood and Drug Administration (CDEW FDA) routinely requests that drug sponsors submit in their New Drug Applications’ carcinogenicity studies electronic data sets for its statistical reviewers to perform independent statistical analyses to evaluate sponsors’ analyses and conclusions. The recommended formats for submission of data are based on the information needs f o r such statistical analyses. Two sets of formats and specifications, that is, the Divisions of Biometrics Formats and Specifications and the Submitter Toxicological Unqorm Data Information Exchange Standard (STUDIES)formats, are currently used by the Divisions of Biometrics. Sponsors can follow one of the two sets of formats and specifications in the preparation for data submission. The Divisions of Biometrics, however, strongly encourage sponsors to submit the data sets in the simpler Divisions of Biometrics formats and specifications. This paper includes a discussion on the methods of statistical analysis routinely used by FDA statisticians in their reviews, and listings of the CDEWFDA formats and specifications in the 3/12/97 oficial document (reference 12). Key Words: Prevalence method; Death-rate method; Onset-rate method; Divisions of Biometrics formats; STUDIES formats; Statistical reviews
INTRODUCTION
the majority of their normal life span. In a carcinogenicity study of a new drug using a series of increasing doses levels, statistical tests for positive trends in tumor rates are usually of greatest relevance and interest in the evaluation of the oncogenic potential of the drug. The Divisions of Biometrics of the Center for Drug Evaluation and Research of the Food and Drug Administration are responsible for conducting statistical reviews of long-term animal carcinogenicity experiments carried out by drug sponsors and submitted to FDA as part of Investigational New Drug (IND) or New Drug Application (NDA) submissions. In addition to reviewing animal carcinogenicity study report sections of sponsors’
ASSESSMENT OF THE RISK of drug exposure in humans includes an assessment of the risk for carcinogenicity in lifetime tests in mice and rats. The primary purpose of a longterm animal carcinogenicity experiment is to determine the oncogenic potential of a new drug when it is administered to animals for *The views expressed are those of the author, and not necessarily those of the Food and Drug Administration. Reprint address: Karl K. Lin, PhD, Expert Mathematical Statistician (Applications in Pharmacology/ Toxicology), Division of Biometrics 11, HFD-715,Office of Epidemiology and Biostatistics, Center for Drug Evaluation
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