How AI Tech Is Changing Regulatory Writing
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For…
CertaraApril 21, 2017
The Model-informed Precision Dosing Revolution Is Coming
Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global…
CertaraMarch 7, 2017
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug
Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a…
CertaraOctober 21, 2016
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…
CertaraSeptember 13, 2016
Arming Adherence-based Drug Development with Pharmacometrics
The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients,…
CertaraSeptember 12, 2016
The Role of a U.S. Agent
Foreign sponsors of drug applications who want to conduct business in the United States need…
CertaraSeptember 6, 2016
Assessing Drug-Smoking Interactions Using PBPK Modeling
The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…
CertaraJuly 29, 2016
Status of QSP Modeling in the Pharmaceutical Industry
A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to…
CertaraJuly 6, 2016
Diving into Best Practices for Pooling Clinical Trial Data
Learn the best practices for pooling clinical trial data. Discover how effective data integration enhances…
CertaraJune 3, 2016
Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to…
CertaraMay 12, 2016
