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.
The process of developing a new drug which targets weakness in the cell is drug development. This process is done in laboratories and tested on animals and people to know the mechanism of action. This process proceeds with several stages to produce safe and effective ones
Developing Drugs is at higher echelons that enhance the intelligence and information dissemination on topics closely related to Developing Drugs. ... The Developing Drugs Peer Reviewed Journals are proficiently supported by universally prominent Editorial Board members.Drug development describes the process of developing a new drug that effectively targets a specific weakness in a cell. This process involves specific pre-clinical development and testing, followed by trials in humans to determine the efficacy of the drug
Phase 1: Discovery and Development. Phase 2: Preclinical Research. Phase 3: Clinical Research. Phase 4: FDA Review. Phase 5: FDA Post-Market Safety Monitoring.
Many aspects of drug development focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs, brain, kidney, liver and digestive system), as well as effects on other parts of the body that might be affected by the drug (e.g., the skin if the new drug is to be delivered through the skin). 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.