Preclinical Toxicity Studies

Abstract

AbstractPreclinical toxicity studies involve testing the newly screened compounds to determine the safety of that compound in at least two different animal species. Based on the time & duration of the study and its objectives, the preclinical toxicity studies can be classified into Acute toxicity studies, Sub-acute toxicity studies, Sub-chronic toxicity studies, and Chronic toxicity studies. Based on the number of doses administered, the toxicity studies can be classified into single-dose toxicity studies (acute toxicity study) and repeated dose toxicity studies (sub-acute, sub-chronic, and chronic toxicity studies). Similarly, based on the area of exposure of interventional drugs in animals, toxicity studies can be divided into systemic toxicity studies (comprises of acute, sub-acute, chronic, sub-chronic, and reproductive toxicity studies) and local toxicity studies (Dermal toxicity, Ocular toxicity studies). This chapter will give a concise review of the selection of animals, selection of dose, duration of the study, types of protocol, and various issues related to each type of toxicological study.KeywordsAcute toxicity studyChronic toxicity studyLocal toxicity studySubacute toxicity studyDermal toxicityOcular toxicity