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Early Drug Discovery and Development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.[1][2]

Contents
1 New chemical entity development
1.1 Pre-clinical
1.2 Clinical phase
2 Cost
3 Valuation
4 Success rate
5 Novel initiatives to boost development
6 See also
7 References
8 External links
New chemical entity development
Broadly, the process of drug development can be divided into preclinical and clinical work.

Timeline showing the various drug approval tracks and research phases[3]
Pre-clinical
Main article: Pre-clinical development
New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is 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 these parameters prior to human clinical trials. A further major objective of drug development is to recommend the dose and schedule for the first use in a human clinical trial (“first-in-man” [FIM] or First Human Dose [FHD]).