Recommendations for Biostatistics of Mutagenicity Studies *

Abstract

A Drug Information Association Workshop on “Statistical Methodology in Non-Clinical and Toxicological Studies” was held at the end of March 1996. The purpose of this meeting was to discuss and to obtain a consensus on the appropriateness of current and new biostatistical methods relevant in this field of drug development. The following summary represents a consensus of the Working Group on Biostatistics in Mutagenicity Studies. The recommendations outline the relevant principles of design and analysis rather than provide detailed specification of statistical methodology, thus providing the possibility of making reasonable choices between alternative approaches.