Toxicology Applications

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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