Research on regulatory environment for pharmaceutical development to improve success rates of new drug development

本研究发现，在全球化发展的时代，新药上市延迟与新药研发成功率之间存在显著的正相关关系，这使我们能够基于不确定性下利润最大化的潜在机制，提出有效的研发政策措施。我们还发现，全球药物开发和监管环境，包括上市后监测的实施，似乎对日本人群的药物安全性和剂量设定产生了影响。这些发现有助于制定新药开发法规和政策。

This research has found a significant positive association between launch delay and success rates of new drug development in the era of global development, which enables us to propose effective R&D policy measures based on the underlying mechanism of profit maximization under uncertainty. We also have found that the global pharmaceutical development and regulatory environment, including implementation of post-marketing surveillance just after launching, seem to have impact on drug safety and dose-setting for the Japanese population. These findings help establish new drug development regulation and policies.