General Pharmacology term is used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery. The process includes the pre-clinical research using microorganisms/animals and clinical trials on humans and may also include the step of marketing the drug with regulatory approval. Before any clinical trials, the researchers file an Investigational New Drug (IND) application with the FDA. The application includes the preclinical work results, the candidate drug's chemical structure and how it is thought to work in the body, a listing of any side effects and information on manufacturing. The IND also provides a detailed clinical trial plan that outline how, where and by whom the studies will be performed.
Last date updated on September, 2020