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
Rare Disease and Orphan Drug Development
There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…
Certara2016 年 8 月 3 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
How to prepare a study data standardization plan (SDSP) for FDA
Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…
Certara2016 年 7 月 25 日
