Generating,Interpreting,and Reporting Information in Toxicity Studies

Abstract

The toxicological evaluation of a compound involves a variety of acute, subchronic, and chronic toxicity studies which over the past decade have greatly increased in size and complexity. The combination of voluminous amounts of data collected in chronic toxicology studies and regulatory requirements for extensive documentation of the toxicology testing process presents an enormous burden when manual processes are used for data collection, storage, and analysis. Toxicology studies using relatively standardized experimental protocols present an ideal opportunity for nearly complete automation and computerization of the data acquisition, storage, analysis, and reporting processes. The complexity of toxicology data collection and the requirement for flexibility to accommodate special needs for individual experiments necessitate, however, the use of sophisticated computer software and hardware on a scale that is often underestimated at the outset of a toxicology computer project by both toxicologists and computer specialists alike. This paper will provide an overview of the types of studies conducted during the toxicological evaluation of a compound, the types of data elements that are collected, and special requirements that are involved in the analysis and reporting of chronic toxicology/carcinogenicity and subchronic toxicity tests. In addition, an attempt will be made to provide a perspective on the magnitude of toxicology data processing involved in the safety evaluation process.