Pharmaceutical Industry: Research and Development
Contemporary research and development within the pharmaceutical industry is best described employing a lifecycle perspective. Four components of this are: drug discovery and drug design; nonclinical development; clinical development; and postmarketing surveillance (Turner, 2010).
Drug Discovery and Drug Design
Drug discovery can be thought of as the work done from the time of the identification of a therapeutic need in a particular disease area to the time the drug candidate deemed most likely to safely affect the desired therapeutic benefit is identified. This drug candidate may be a small molecule or a biological macromolecule such as a protein or nucleic acid. The traditional mode of drug discovery is a long iterative process in which each molecule more closely approximates the ideal drug candidate. The modern discipline of drug design is much quicker. Computer simulation modeling examines the “docking” of the...
References and Readings
- ICH E8. (1997). General considerations for clinical trials. Accessed April 09, 2011, from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf
- Turner, J. R. (2010). New drug development: An introduction to clinical trials. New York: Springer.Google Scholar