ABSTRACT
This chapter presents the number quality, and timing of animal studies which precede or accompany clinical trials; also, on the use of animal toxicology data in conducting clinical trials; and, finally, on the areas where preclinical studies are of no value or can be misleading. Drug safety evaluation or safety assessment or pathology and toxicology studies, as they are variously known, play an important role in every phase of drug development from the preclinical identification of early biological activity of possible therapeutic interest to postmarketing activities. Interpretation of the results of subacute studies has not received as much attention as it should in toxicology monographs and textbooks. In carcinogenicity experiment designs, the objectives are to minimize stress by reduced handling and to maximize survival so that an adequate number of survivors is present at the end of the study to assess relatively small differences in tumor incidence between treated and control groups.
