Certara s Senior Vice President and General Manager for Software Products and Consulting Services, said, Christine s experience and leadership in the field of cardiac safety assessment will be particularly valuable as we execute on our plans to advance the capabilities of Phoenix, our platform of pharmacometric
analysis and modeling tools, and to further enhance the services that we provide to our clients to improve drug development productivity and decision-making.
Joga Gobburu, University of Maryland, Baltimore, will present a webinar, “Impact of Pharmacometric
Analyses on New Drug Approval and Labelling Decisions” on Tuesday, March 20, 2012 at 1:00 to 2:00 pm EST as part of Rosa's ongoing monthly public webinar series.
Gobburu is best known for transforming the field of pharmacometrics
across the world into a decision-supporting science, and his background includes a stint at the FDA, where, under his direction, the Division of Pharmacometrics
(DPM) was formed.
The winning submission will be announced at the American Conference on Pharmacometrics
(ACoP) to be held April 4-7, 2011 in San Diego, California.
FDA approval of biweekly (every two weeks) dosing for Hizentra is based on the principles of pharmacometrics
and pharmacokinetic modeling.
The 2nd annual ISQP symposium will discuss the latest methodologies in pharmacometrics
areas focusing on pharmacokinetics and pharmacodynmics (PK/PD) modeling and simulation in drug development, regulation and clinical applications.
Lesko, PhD, FCP, Professor of Pharmaceutics, Director, Center for Pharmacometrics
and Systems Pharmacology, University of Florida College of Pharmacy
The Phoenix Centers of Excellence Program is a collaboration with Pharsight to enhance research and training in pharmacometrics
at several elite academic centers.
Figure 10: Pathways to Efficient Drug Development, Disease, Drug and Trial Models: Pharmacometrics
in Drug Development 39
Lessons Learned from Thorough QT and Simulation of CV Outcomes Using Available BP Data Rajanikanth Madabushi, PhD Pharmacometrics
Reviewer, CDER FDA, United States
of stilbenes: seguing towards the clinic.
- modeling and simulation to improve Phase 1 safety 116