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
Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity
Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…
Certara2024年10月31日
Mathematical Modeling and the Monkey King: Use of Modeling for More Efficient NHP Study Design
Background Monkeys and humans share a strong bond, reflected not only in a shared genetic…
Certara2024年10月30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
Three Strategies for Navigating the Pharmaceutical Patent Cliff
In the pharmaceutical industry, the end of a product's patent protection, known as the loss…
Certara2024年10月21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
Using Define-XML for Faster, Better Quality and More Efficient Studies
We explore progressive uses of Define-XML in trials, and why you should design submission datasets…
Certara2024年9月25日
How to Use CDISC’s ODM Standard for CRF Design
Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium…
Certara2024年9月25日
How Clinical Trial Technology Streamlines the Research Process
Learn how innovative clinical trial technology helps to revolutionize research & ensure the swift rollout…
Certara2024年9月25日
