Food and Drug Administration Rockville Maryland USA

The history of clinical pharmacology over the past 100 years may be thought of as a gradual progression from the use of potions and other sometimes dubious concoctions to the complex drug development process seen today [1]. The future of clinical pharmacology has been described as academia, industry, and government working together to advance science, develop new drugs, and improve the quality of life of mankind [2]. Efforts such as the International Conference on Harmonization (ICH) have promoted unification of regulatory policies, including those related to clinical pharmacology. More than 35 harmonized ICH Guidelines are available [3] and the recently harmonized Common Technical Document provides for a common format for new drug and biological regulatory submissions. Following are perspectives from Europe and the United States on the progress of clinical pharmacology over the years, in these two major regions of the world.

* Current affiliation: Barrier Therapeutics, Princeton, New Jersey, U.S.A.

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