GCP 标准下临床试验数据呈现及中国人群数据缺失问题
- 重点是如何按照 GCP 要求呈现临床试验数据；
- 难点是没有中国人群数据，日本已上市之后有没有数据？如果有，日本已上市数据和博鳌的数据可以增加到 '3.4 临床经验数据（上市后随访研究）' 内容：
- The focus is on how to present clinical trial data in accordance with GCP requirements;
- The challenge is that there is no data on Chinese populations, is there any data available after the product has been launched in Japan? If so, the data from Japan's launch and from Boao can be added to '3.4 Clinical Experience Data (Post-Market Follow-up Study).'
原文地址: https://www.cveoy.top/t/topic/f2kV 著作权归作者所有。请勿转载和采集!