Drug development 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.
There have been many great discoveries in drug development that have benefited mankind. Recent developments include the human genome unraveling, which is the genetic blueprint for building a human being. Understanding on how the human system works on a molecular level, allows the scientists to create better therapies to prevent, treat and cure the diseases. Other achievements in the drug development are the discovery of the polio vaccine, antibiotics, biotechnology, computer modeling and modern analysis. The aim of researchers in drug development is to produce safe and effective therapeutic products for the promotion of health, and the prevention and treatment of diseases.
Last date updated on June, 2014