FDA’s New Module 1 is a Bridge to eCTD 4
Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group…
Certara2016年9月13日
Arming Adherence-based Drug Development with Pharmacometrics
The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients,…
Certara2016年9月12日
The Role of a U.S. Agent
Foreign sponsors of drug applications who want to conduct business in the United States need…
Certara2016年9月6日
Assessing Drug-Smoking Interactions Using PBPK Modeling
The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…
Certara2016年7月29日
Status of QSP Modeling in the Pharmaceutical Industry
A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…
Certara2016年7月6日
Diving into Best Practices for Pooling Clinical Trial Data
Learn the best practices for pooling clinical trial data. Discover how effective data integration enhances…
Certara2016年6月3日
Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to…
Certara2016年5月12日
Submitting eCTD in Advance of a Milestone Application
While advanced GPS systems and the advent of Big Data analytics are negating some of…
Certara2016年5月10日
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…
Certara2016年3月14日
Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland
Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation…
Certara2016年2月23日
