JIST

Abstract

As per the international regulations and rules of US Food and Drug Administration (FDA), toxicological

screening of a new molecule is an essential step before establishing its pharmaceutical activity. The preclinical toxicity testing of a substance on various biological systems reveals the dose specific toxic effects of an investigational product. The toxicity tests are mostly used to examine specific adverse events of the investigational product.

In general, toxicity studies should be carried out over a minimum three doses in two different species, but there could be other ways to measure the toxicity of a substance. In India, any form of toxicological testing must be carried out according to guidelines laid out by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), and the study should be approved by an Institutional Animal Ethics Committee.

This review mainly highlights the importance of toxicological screening, different types of toxicity studies, toxicological assay techniques and ethical and other toxicological regulations.