Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi‐Regional Clinical Trials and Future Pathways

Résumé fourni par la source

A new guideline clarifying basic principles for conducting a phase 1 trial in Japanese prior to multi-regional clinical trials was issued in December 2023 to streamline global drug development and accelerate access to novel drugs. To foster a shared understanding of the guideline and discuss future pathways, the regulatory agency and industry jointly organized a public symposium. This report summarizes the proceedings of the symposium.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.