PRINCETON, NJ – Dec. 20, 2017 – Certara today congratulated Medicines Development for Global Health (MDGH), a not-for-profit global health company, on the submission of its new drug application (NDA) for moxidectin as an oral treatment for river blindness (onchocerciasis).
In this webinar, Professor Jean-Michel Cardot explained how to perform Level C IVIVC using Phoenix. Learn how to calculate pharmacokinetic parameters via the non-compartmental analysis module; how to calculate dissolution parameters via the dissolution module; how to link the in vivo pharmacokinetic parameters and in vitro dissolution parameters via the linear relationship module; and how to calculate dissolution limits.
PRINCETON, NJ – Dec. 8, 2017 – Certara announced that Leigh Farrell, PhD, Vice President of Corporate Strategy and Business Development, is presenting the inaugural Certara New Investigator Awards in association with the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
Watch this webinar with Nikunjkumar Patel, Oliver Hatley, and Matthew Harwood to learn how the latest updates in the Simcyp Simulator v17 will help provide insights that support developing safer, more effective medications.
PRINCETON, NJ – Dec. 4, 2017 – Certara today announced that it has launched version 17 of its Simcyp Population-based Simulator.
Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.
Modeling and simulation can help guide critical decisions around dosing and toxicity, efficacy and mechanism of action, clinical trial design and cohort selection, and commercial probability of success as compared with existing therapies or others in development.
PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.