Pharmacologic Considerations in the Design of Toxicology Experiments

Abstract

Final assessment of product acceptance must be based on value judgments that include (a) social, (b) economic, and (c) environmental factors as well as risk factors, and not on simple safety statements about the end product. The goal of toxicologic experiments should be to provide sufficient data to allow benefit-to-risk judgments about products. Benefit-to-risk judgments need to be made on a broad data base which includes: manufacturing, distribution, and use factors. Safety assessments begin with concerns associated with initial manufacture of raw materials and end with concerns related to disposal of the end products of use. Current experimental design needs to include biopharmaceutic considerations of the dose form, pharmacokinetic aspects, and pharmacodynamic factors as well as pathologic concerns. These factors stress the point that toxicology is a quantitative science because toxicity resides in the dose and dose form and not in the chemical entity.