Drug Discovery, NCEs and Drug Development

Drug discovery is the process in which potential new medicines are recognized and comprises an effective range of scientific disciplines, including biology, chemistry and pharmacology. The integration of pharmacodynamics and pharmacokinetic parameters in non-clinical pharmacology studies plays a key role in drug discovery for efficacy and safety assessment, in particular for translation from the non-clinical to clinical field and process of drug discovery include  the identification , synthesis, characterization, screening, and assays for therapeutic efficiency and modern drug discovery involves the identification of screening areas, medicinal chemistry and optimization of those areas to increase the affinity, selectivity, efficacy/potency, metabolic stability, and oral bioavailability.

FDA provides scientific and regulatory advice to bring new therapies to market. In 2018, FDA has approved 43 new drugs which are currently in the market. Every year, CDER approves series of new drugs and biological products. The availability of new drugs represents new treatment options for patients and advances in health care. Some of these are often innovative new products that never before have been used in clinical practice. A new chemical entity (NCE) is a drug that contains no active molecule that has been approved by the FDA in any other application submitted under the Federal Food, Drug, and Cosmetic Act.