Rolling NDA and BLA Submissions: Accelerate Your Review Timeline
We look at the growing regulatory trend of rolling NDA and BLA submissions to help…
Certara2025 年 2 月 3 日
Anonymization vs. Redaction of Clinical Trial Data
2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
Certara2025 年 1 月 17 日
CDISC SEND Updates Nonclinical Drug Developers Need to Know
In this blog, Peggy Zorn explores updates to the Standard for Exchange of Nonclinical Data…
Certara2024 年 12 月 3 日
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
Certara2024 年 6 月 19 日
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
Certara2024 年 5 月 22 日
什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
Certara2022 年 2 月 2 日
