In the development of medicines and vaccines, industry practice and government regulations in the United States and most other developed countries require the sponsor to demonstrate the safety and efficacy of its products. Extensive data from preclinical and clinical studies are provided to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and other regulatory agencies to gain approval of a medicine or vaccine.
Once a new compound is identified that has promise to treat a medical condition, preclinical testing is started. Preclinical testing includes laboratory testing and animal safety studies to gather data on chemistry, pharmacology and toxicology. To foster greater productivity in research, newer and more sophisticated techniques are being used, such as pharmacogenomics and regenerative medicine research.

The content on this page was last modified on October 24, 2008