ABSTRACT
Clinical pharmacology plays a role throughout the development process of drugs in all therapeutic classes. Three conferences convened during the 1990s addressed the utility of clinical pharmacology information in the drug development process. The first conference, “The Integration of Pharmacokinetic, Pharmacodynamic, and Toxicokinetic Principles in Rational Drug Development,” occurred in 1991 in Arlington Virginia. The other meetings were held in 1998: “AAPS, ACCP, ASCPT, FDA Symposium on Clinical Pharmacology: Optimizing the Science of Drug Development” in Arlington, Virginia, and “5th EUFEPS Conference on Optimizing Drug Development:
Fast Tracking into Human,” in Wiesbaden, Germany. The conference report for the 1991 meeting indicates that the coordinated application of pharmacokinetics and pharmacodynamics provides a rationale approach to efficient and informative drug development [1]. The report for the two 1998 conferences states that there are a number of opportunities for the use of clinical pharmacology principles at every step of the drug development process. Appropriate use of clinical pharmacology information allows one to identify and develop the best drugs with low risk potential and also to identify failures faster [2]. Earlier chapters in this book (Chapters 1, 2, and 4) elaborate on the utility of clinical pharmacology in drug development.
