MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Watch this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.
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.
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.
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.
In this webinar, Dr. Nathan Teuscher demonstrated how to get the most out of Phoenix 8.0’s new features, including how to automatically calculate new NCA parameters, set up parallelization of Phoenix NLME runs, and leverage the new validation suite to get up and running in no time.
Watch this webinar with Drs. Carl Kirkpatrick and Craig Rayner to learn how “pharmacology to payer” (P2P) can be used as a quantitative framework that bridges the disciplines of pharmacology, epidemiology, and health economics to support meaningful dialogue between industry, regulators, and payers.
In this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.
In this webinar, Mr. Steve Sibley defined best practices for establishing submission timelines that won’t change, addressed regional differences to minimize document re-work when submitting to multiple countries, and identified leadership and project management skills helpful to regulatory writing.
In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).
In this webinar, Dr. Tom Snowden demonstrated: why reduction methods are a potent and necessary tool in the modeler’s arsenal; how reduction methods can be applied to QSP models; and, how model reduction can be used to extract scientific and business insights from complex models.