Everything You Need to Know About SDTM
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…
Certara2024 年 3 月 12 日
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
罕见病是公共卫生领域的优先事项。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
动物规则 -- 如果临床试验根本不符合道德规范怎么办？
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
