Abstract
Outlines of two guidelines related to pharmacokinetics of guidelines recently adopted in ICH, general guideline (E8) and timing guideline (W), were explained. Both guidelines show that exposure data in animals should be evaluated prior to human clinical trials, and that further information on absorption, distribution, metabolism and excretion in animals should be made available by the time the human pharmacology studies have been completed. This means that pharmacokinetics and ADME data in animals are important at the evaluation of human safety and metabolic pathways.
Two cases in which the Organization for Pharmaceutical Safety and Research (OPSR) advised the sponsor in the clinical trial consultation to take measures to ensure the safety of human subjects because of the discrepancy of pharmacokinetics data between animals and human beings were presented.
It is shown that pharmacokinetics and ADME data are important to evaluate the connections between animals and human beings, healthy adults and patients, adult patients and specified sub-populations such as the elder patients, kidney and liver dysfunction patients. It is expected from now on to develop the pharmacokinetics parameters closely related to the pharmacological effect and their convenient assays.
