Drug development process toxicological phase

The pre-clinical drug development process has as its end product a drug candidate that is suitable for testing in human clinical trials. To achieve this, the candidate must pass pre-clinical toxicology testing, have its adsorption, distribution, metabolism and excretion understood in suitable animal models, and have good scientific evidence that it will provide medicinally beneficial effects. The latter normally requires showing efficacy in animal models of the disease. The early phase discovery process has usually... 

All new clinical staff need to understand the overall drug development process. Before new investigational products can be introduced into man, extensive preclinical and toxicological studies are performed. Staff who will be responsible for the clinical portion of drug development need to have an appreciation of the work that has been undertaken to progress the compound through to the clinical phases. 

High-throughput toxicological assays to determine the issues of molecules still in a relatively early phase of the drug discovery process are extremely important, and several academic and private groups are active in this field to develop predictive... 

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