Full Description
Proceedings of a conference sponsored by the American Association of Pharmaceutical Scientists, the U.S. Food and Drug Administration, and the American Society for Clinical Pharmacology and Therapeutics, held in Arlington, Virginia, April 24-26, 1991
Contents
Rationale for the Effective Use of Pharmacokinetics and Pharmacodynamics in Early Drug Development.- The Case for Preclinical Pharmacodynamics.- Utility of Kinetic, Dynamic, and Metabolic Data in Nonclinical Pharmacology/Toxicology Studies.- Preclinical Pharmacokinetic & Pharmacodynamic Studies.- Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal Models).- Nonclinical Considerations: Disposition of Drugs.- Use of Acute Toxicity Data in the Design and Interpretation of Subchronic and Chronic Toxicity Studies.- Use of Pharmacokinetics and Pharmacodynamics in Preclinical Studies to Guide Dosage Escalation Schemes in Phase I Studies of Anticancer Drugs.- Use of Toxicokinetic Principles in Drug Development: Bridging Preclinical and Clinical Studies.- Methodology for Preclinical Pharmacodynamic Studies.- Preclinical Pharmacodynamics of Central Nervous System Active Agents.- Preclinical Pharmacodynamics of Antihypertensives.- Preclinical Pharmacodynamics of Anxiolytics: Effects of Chronic Benzodiazepine Administration.- Guidelines for Development of a New Diuretic Agent.- Preclinical Pharmacodynamics of Anti-Inflammatory Drugs.- Preclinical & Clinical Pharmacokinetics.- The Role of Pharmacokinetics in the Drug Development Process.- Implementation of an Effective Pharmacokinetics Research Program in Industry.- Pharmacoepidemiology, Population Pharmacokinetics and New Drug Development.- Assessment of Pharmacokinetic Drug Interactions in Clinical Drug Development.- Clinical Pharmacodynamics.- Pharmacokinetic/Pharmacodynamic Models and Methods.- Pharmacokinetic and Pharmacodynamic Modeling Applied to Anesthetic Drugs.- Pharmacodynamic/Pharmacokinetic Relationships for Rapidly Acting Drugs (NSAIDS) in Rheumatoid Arthritis: Problems and Preliminary Solutions.- The Value of Plasma-Warfarin Measurement.- Clinical Pharmacodynamics of Cardiovascular Agents: Focus on Sudden Cardiac Death.- The Benzodiazepines: Kinetic-Dynamic Relationships.- Application of Pharmacodynamics & Pharmacokinetics in the Drug Development Process.- The Integration of Pharmacodynamics and Pharmacokinetics in Rational Drug Development.- Concentration-Controlled Trials: Basic Concepts, Design, and Implementation.- Summary Report.- Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development.
