Application of pharmacokinetic methods to the drug residue profile.

A pharmacokinetic approach to the delineation of a drug residue profile in food-producing animals has been presented. It is recognized that the determination of a drug withdrawal period is one of the costly developmental procedures in drug development for food animals; thus it is believed that in the early developmental phases, a thorough pharmacokinetic characterization of a drug in the target species would greatly facilitate the design and quality of studies conducted in the later phases of new drug development. It is suggested that drugs that are intended for use in food animals can be characterized kinetically in less costly studies, the results of which might be used to determine the feasibility of developing a drug that might cause serious residue problems. It is also suggested that the pharmacokinetic modeling of a drug in the target animal may provide an essential data base for calculating dosage rates and intervals that directly relate to the efficacy aspects of drug development.