FAQs on Developing EMA Policy 0070 Submissions Blog 制定 EMA 政策0070 提交材料的常见问题解答 In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…Certara2024 年 11 月 1 日
How To Respond to Health Authority Questions Blog How To Respond to Health Authority Questions Your biotech company has just submitted the marketing application for your first drug product. It’s…Certara2024 年 10 月 25 日
Why You Need an Integrated Development Plan Blog 为什么需要药物综合发展计划? Learn about the Integrated Development Plan for successful drug development & its relation to the…Certara2024 年 10 月 17 日
Why cancer drug programs need human mass balance studies Blog 为什么癌症药物项目需要人体物质平衡研究 Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…Certara2024 年 9 月 23 日
Resmetirom: A pioneering NASH clinical program Blog Resmetirom: A pioneering NASH clinical program Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…Certara2024 年 8 月 23 日
Subject Exposure in Aggregate Safety Reports & Common Issues Blog Subject Exposure in Aggregate Safety Reports & Common Issues All new and existing drugs should be safe, effective, and efficacious for the treated populations.…Certara2024 年 8 月 16 日
临床开发计划如何帮助药物项目? 博客 临床开发计划如何帮助药物项目? How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…Certara2024 年 7 月 26 日
什么是科学与医学出版专业人士? 博客 什么是科学与医学出版专业人士? Would your drug development program benefit from partnering with experts in scientific and medical communications…Certara2024 年 7 月 19 日
Generative AI Tools for Regulatory Writing Blog 用于法规撰写的人工智能生成工具 监管文件撰写是药物开发过程中的重要组成部分。Regulatory writers must understand…Certara2024 年 6 月 20 日