Toxicology Skills for Drug Discovery
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چکیده
The development of novel pharmaceuticals requires non-clinical safety studies to be performed on candidate drugs. Such studies typically assess general toxicology (as determined by in vivo experiments), safety pharmacology (effects on major organ systems, e.g. cardiovascular) and genetic toxicity test batteries. These studies inform progression of candidate drugs from the “discovery phase” through clinical development to regulatory submission and registration. However traditionally, less emphasis was placed on the evaluation of safety issues for projects while still in the drug design phase. Consequently, this led to a number of significant failures of candidate drugs in early development due to toxicological issues. In response to this costly attrition, many pharmaceutical companies have now invested in “Discovery-phase Toxicology” or “Discovery Safety” to identify potential hazards and to take steps to design out or significantly reduce undesirable properties at an earlier stage, with the ultimate aim of enhancing the probability of success in non-clinical and clinical drug development.
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