Abstract
AbstractThe primary objective of toxicology studies in the drug development process is to evaluate the safety of potential drug candidates using relevant animal models and validated procedures. The ultimate goal is to interpret the animal data to assess risk for human subjects/patients. Therefore, the toxicologist must be aware of the international guidelines for safety evaluation in conjunction with the use of traditional and nontraditional models such as transgenic animals. This overview discusses the components of a typical toxicology profile including safety pharmacology, genetic toxicology, acute and subchronic toxicology, chronic toxicology, absorption, distribution, metabolism and excretion (ADME) studies, reproductive and developmental toxicology, and an evaluation of carcinogenic potential. (Due to the wide variety of therapeutic targets, toxicology profiles may differ from drug to drug.) Also, regulatory guidelines for toxicology testing are explained in relation to the drug discovery and development process.
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