Utility of Kinetic, Dynamic, and Metabolic Data in Nonclinical Pharmacology/Toxicology Studies

Abstract

Kinetic, dynamic, and metabolic data can be used to predict the appropriate studies, doses, duration, route of administration, species, and dosage interval in toxicology studies coordinated with drug development These data are used to predict starting and maximal doses in human studies, and when evaluated in conjunction with the data obtained in human pharmacokinetic studies, serve as an index for animal to human comparisons and extrapolations The optimal use of kinetic and dynamic information in standard pharmacologic and toxicologic studies will be presented. Reference will be made to problems encountered in the absence of these data and protocol development advantages where these data are incorporated. Development of pharmaceuticals, without incorporating kinetic and dynamic information, is currently associated with more costly, more time consuming, less utilizable knowledge and subsequent studies are often needed to explain anomalous results.