FAQs on Developing EMA Policy 0070 Submissions
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
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
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
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
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
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？
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？
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
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
