ABSTRACT

Repeated-dose toxicity studies are conducted to screen for potential adverse effects of compounds such as pharmaceuticals (small molecules as well as biological agents), pesticides, food additives, or other chemicals using laboratory animals as surrogates for the intended exposed population or target species, most often the human. Repeated-dose studies may be of varying duration, generally 1-4 weeks for short-term studies, 3 months for subchronic studies, and 6-12 months for chronic studies. Many parameters indicative of the health of the test species are monitored in short-term, subchronic, and chronic toxicity studies, resulting in the ability to detect a variety of adverse effects, identify alterations due to exaggerated pharmacology, and/or assess the reversibility of •ndings. Sometime during their career, most toxicologists are involved in designing, performing, monitoring, or reviewing data from these types of toxicity studies as a result of the central role of these studies in safety assessment.