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Strategies in Selecting an Agent for Clinical Trials

Drug development is a long and expensive process. Despite the great advances in understanding of disease pathology and in scientific technology, development times are increasing. Pharmaceutical companies, who are responsible for the development of most new drugs are keen to reduce the level of risk associated with drug development. They are attempting to rationalize the process of discovery and early development in order to reduce the risk of a drug proving unsafe or ineffective late in development. In this article, I will first describe the present and historical forces that shape the current approach to discovery of potential new molecular entities, both chemical and biological. I will then discuss how preclinical and exploratory human studies can assist in picking compounds most likely to be safe and effective.