An Automated System for the Statistical Evaluation of Developmental Toxicology Data

Abstract

The objective of developmental and reproductive toxicity studies performed at Merck Sharp & Dohme Research Laboratories is to evaluate a compound's effects on fertility and to assess its effects on offspring exposed in utero and during lactation. Many of the studies follow from a well-defined set of experimental designs. To avoid delays in processing time and to allow statisticians to concentrate efforts in areas other than performing standard analyses, the Data Coordination Unit within Safety Assessment submits batch jobs which generate output from standard statistical routines. The software was written by Computer Resources in consultation with Biometrics Research. Computer systems validation procedures were carried out to verify that the application programs provided the intended results and to satisfy Food and Drug Administration (FDA) guidelines for systems development documentation. The total data processing system is referred to as the Developmental and Reproductive Toxicology Statistical Software System (DARTSSS).