APPW2025

Chairperson：Kenichiro Hayashida（Shin Nippon Biomedical Laboratories, Ltd. Department of Pharmacology）

Co-hosted by: Shin Nippon Biomedical Laboratories, Ltd.

In pharmaceutical development, the ICH-M3(R2) guideline (2010) states that the evaluation of drug abuse potential should be considered for CNS-active drugs, regardless of the indication. Furthermore, each of the three major regions—Japan, the United States, and Europe—has its own guidelines on drug dependence and conducts evaluations of drug dependence/abuse potential accordingly. Drug dependence is assessed through multiple studies, each yielding characteristic data. This seminar will introduce the key features and evaluation methods of the guidelines from these three regions and explain the multifaceted interpretation of the characteristic data.