ISSN: 2041-6792

Clinical Investigation

Developing Drugs Articles Open Access

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. These have promising activity against a specific biological target that's important in disease. However, little is known about the safety, toxicity, pharmacokinetics, and metabolism of this NCE in humans. It is the function of drug development to assess all of those parameters before human clinical trials. These generally constitute variety of tests designed to work out the main toxicities of a completely unique compound before first use in humans.  Increasingly, these tests are made using in vitro methods (e.g., with isolated cells), but many tests can only be made by using experimental animals to demonstrate the complex interplay of metabolism and drug exposure on toxicity. The information is gathered from this preclinical testing, as well as information on CMC, and submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug (IND) application. They further examine the merchandise for suitability to package as capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, or intravenous formulations. Together, these processes are known in preclinical and clinical development as chemistry, manufacturing, and control (CMC). Many aspects of drug development specialise in satisfying the regulatory requirements of drug licensing authorities.

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