Biomedical Research

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Drug Development

 

Drug development is the process of making a replacement of pharmaceutical drug in the market, once a lead compound has been identified by the method of drug discovery. This process includes research of preclinical studies 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 should include the step of obtaining regulatory approval with a replacement drug application to plug the drug.

Many aspects of drug development specialise in satisfying the regulatory requirements of drug licensing authorities. These generally constitute variety of tests designed to work out the main toxicities of a completely unique compound before first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the guts and lungs, brain, kidney, liver and digestive system), also as effects on other parts of the body which may be suffering from the drug (e.g., the skin if the new drug is to be delivered through the skin).  

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