New drug development

Once a novel anti-cancer agent has been discovered, its structure and pharmacological and pharmaceutical properties optimized, and a decision made to test it in humans, a number of well-defined stages must be passed before the compound can enter clinical trials. The drug development process is very closely regulated to ensure the quality of preclinical and clinical data and to protect the safety and the rights of the human subjects participating in the trials. Therefore, the requirements of the regulatory authority in the country where the trials are to be performed must be considered.

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