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What’s New in the Simcyp Simulator v17?

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.

Speaker(s): Nikunjkumar Patel, Matthew Harwood, Oliver Hatley
Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Best Practices in Clinical Pharmacology Gap Analysis

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.

Speaker(s): Julie Bullock
Solution: Clinical Pharmacology Strategy
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How Can You Get the Most out of Phoenix 8.0?

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.

Speaker(s): Nathan Teuscher
Solution: PK/PD Modeling & Simulation
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Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

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.

Speaker(s): Angela Colbers, Rick Greupink
Solution: PBPK Modeling & Simulation
Therapeutic Area: Infectious Disease
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Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

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).

Speaker(s): Jean-Francois Marier, Barry Mangum
Solution: Drug Development & Regulatory Strategy
Therapeutic Area: Pediatrics
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Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

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.

Speaker(s): Tom Snowden
Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
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Obeticholic Acid—From PK Model to Drug Label

Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

Speaker(s): Jeffrey Edwards
Solution: PK/PD Modeling & Simulation
Therapeutic Area: Rare/Orphan Disease
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