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
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
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
How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients
Immuno-oncology, which harnesses the patient's own immune system to fight cancer, is one of the…
Certara2016年2月16日
Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?
An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters…
Certara2016年2月9日
Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko
Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…
Certara2015年12月1日
