Toxicology Applications

Application of procedures and principles of toxicology to prevent adverse health effects from drug candidates. To estimate the safety of potential drug candidates in the drug development process is the primary objective of toxicology studies. This can be done by using relevant animal models and validated procedures. The ultimate goal is to translate the animal model responses into an understanding of the risk for human subjects. To this end, the toxicologist must be conscious of the international guidelines for safety evaluation, as well as traditional and nontraditional toxicology models. Toxicology profile consists of safety Pharmacology, acute and sub chronic toxicology, chronic toxicology, ADME studies, genetic toxicology, reproductive and developmental toxicology and an evaluation of carcinogenic potential. The development of novel drugs requires non-clinical safety studies to be performed on candidate drug compounds. Such studies typically assess general toxicology safety pharmacology and Genetic Toxicity test batteries. These studies notify development of candidate drugs from the “discovery phase” through clinical development to regulatory submission and registration. Less importance was placed on the evaluation of safety issues for projects while still in the drug design phase. Therefore, this led to a number of major failures of candidate drugs in early development due to toxicological issues. In response to this costly attrition, many pharmaceutical companies have now dedicated in “Discovery-phase Toxicology” or “Discovery Safety” to detect likely hazards and to take steps to design out or significantly reduce unwanted properties at an earlier stage, with the ultimate aim of improving the probability of success in non-clinical and clinical drug development.

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