Application of pharmacokinetics in drug safety evaluation

The discipline of pharmacokinetics plays an important role in safety evaluation of drugs. In this presentation various kinds of pharmacokinetic studies have been discussed with specific examples of the studies that should be conducted in support of safety evaluation of new drugs. The design and evaluation of toxicologic and pathologic studies in animals, as well as of safety and efficacy studies in man, should take into consideration the pharmacokinetic characteristics of drugs.