Role of the Pharmacokinetic Data in the Evaluation of New Drug and the Purpose of the Revision of the Japanese Guidelines on Non-clinical Pharmacokinetic Studies

Abstract

Pharmacokinetic data plays an important role in the evaluation of new drugs. They help to extrapolate data of in vitro to those of in vivo, to correlate data of non-clinical pharmacological experiments with those of clinical trials, and also to predict the possibility of drug interaction. The role of pharmacokinetic data in the process of review of pharmacological data in NDA was explained. The purpose of the on-going study to revise Japanese Guidelines for Non-clinical Pharmacokinetic Studies and the discussions in the working group were also introduced.