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Summary of Drug Development

Clinical Development, also called Drug Development, could be a blanket term accustomed define the whole process of bringing a replacement drug or device to the market. It includes drug discovery / development, pre-clinical research (microorganisms/animals) and clinical trials (on humans). Few people still ask the drug development as mere preclinical development.

Drug development is that the process of bringing a replacement pharmaceutical drug to the market once a lead compound has been identified through the method of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, like via the us Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and will include the step of obtaining regulatory approval with a replacement drug application to promote the drug. the complete process - from concept through preclinical testing within the laboratory to trial development, including Phase I-III trials - to approved vaccine or drug typically takes over a decade.