Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)

Resumo

Several issues with pharmacokinetic studies of new drugs, in particular, experiment planning, development of study protocols, dose selection, and administration routes, are reviewed. The number of used animals is justified statistically with respect to bioethics. The pharmacokinetic study protocol is discussed in more detail according to domestic regulatory requirements. Modern approaches to combining bioanalytical methods with pharmacokinetic studies are described.