Opportunities for integration of pharmacokinetics, pharmacodynamics and toxicokinetics in rational drug development: Sponsored by the American Association of Pharmaceutical Scientists, U.S. Food and Drug Administration and American Society for Clinical Pharmacology and Therapeutics

Abstract This report derives from the conference on ‘The Integration of Pharmacokinetic, Pharmacodynamic and Toxicokinetic Principles in Rational Drug Development,’ held on April 24–26, 1991 in Arlington, VA. The conference was sponsored by the American Association of Pharmaceutical Scientists, U.S. Food and Drug Administration and American Society for Clinical Pharmacology and Therapeutics. The objectives of the conference were: (1) To identify the roles and the interrelationships between pharmacokinetics (PK), pharmacodynamics (PD) and toxicokinetics (TK) in the drug development process. (2) To evolve strategies for the effective application of the principles of pharmacokinetics, pharmacodynamics and toxicokinetics in drug development, including early clinical trials. (3) To prepare a report on the use of pharmacokinetics and pharmacodynamics in rational drug development as a basis for the development of future regulatory guidelines.