Sitting around the Certara’s Raleigh office conference room, sketching out a pitch for a pharmacometrics contest at a national meeting, none of us were overly confident in its viability. Mark Lovern had been talking about the importance of communication skills for pharmacometricians. For them to influence critical drug development decisions, they should be able to … Continued
Infants face a gap in protection against influenza between birth and the time of vaccination. Thus, maternal immunization is the only way to prevent flu infection in pregnant women and newborns. Our current understanding of the optimal timing of vaccination is rudimentary. Watch this webinar with Dr. Michael Dodds to learn how modeling and simulation (M&S) offers an alternate approach to dedicated clinical studies to determine the best time to vaccine pregnant women against influenza.
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit … Continued
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk … Continued
PRINCETON, NJ – Apr. 12, 2018 – Certara today announced that it has acquired Analytica Laser, a global research consultancy that uses health economics and outcomes research (HEOR) and real-world data to provide the highest level of scientific evidence of the value of medicines and health technologies.
With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a … Continued
PRINCETON, NJ – Apr. 5, 2018 – Certara and faculty at the UNC Eshelman School of Pharmacy today announced the winners of the first Model-informed Drug Development (MIDD) Gran Prix. The event finals were held on March 24 at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
Watch this webinar with Drs. Lora Hamuro and Joga Gobburu to learn how they developed a natural history progression model for DMD using the 6MWT.
