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
