Best Practices for a Successful eCTD Submission
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…
Certara2024年3月5日
How to Navigate the FDA Landscape for an Orphan Drug
希少疾患は公衆衛生上の優先事項です。FDA has launched several programs and a final…
Certara2024年2月21日
Dose Optimization Considerations for Targeted Radiation Therapies
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio…
Certara2024年2月16日
Navigating Market Access for Healthcare Products: The Power of the Global Value Dossier
This blog defines the global value dossiers and explains how BaseCase can support creating interactive…
Certara2024年1月24日
Understanding the Role of Your Discovery Asset’s Target Product Profile
If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly…
Certara2024年1月19日
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…
Certara2023年12月12日
Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies
Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and…
Certara2023年11月17日
The “Animal Rule” – What if a clinical trial simply isn’t ethical?
Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy. Sometimes, the…
Certara2023年11月10日
Can’t ChatGPT Do That? Practical Applications for AI in Drug Discovery & Development
Explore how Certara.AI tackles the limits of generalized GPTs like ChatGPT to transform drug discovery,…
Certara2023年10月31日
How Biosimulation & AI Tech Could Solve Pharma’s R&D Productivity Crisis
医薬品開発には骨の折れるほど時間がかかり、気の遠くなるような費用がかかります。In a 2010 article, Stephen…
Certara2023年10月27日
