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
Phoenix NLME, The Modern PK/PD Modeling Software for Today’s Scientists
Phoenix NLME is the PK/PD modeling software that is user-friendly and easy-to-learn. Built from the…
CertaraSeptember 12, 2016
D360 Express Scientific Data Informatics Hub
D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical…
CertaraSeptember 9, 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
Rare Disease and Orphan Drug Development
There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…
CertaraAugust 3, 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
