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Agreeing to Submission Document Timelines & Sticking to Them: Fairy Tale or Reality?

September 14, 2017 – In this webinar, Mr. Steve Sibley will define best practices for establishing submission timelines that won’t change, address regional differences to minimize document re-work when submitting to multiple countries, and identify leadership and project management skills helpful to regulatory writing.

Speaker(s): Steve Sibley
Solution: Regulatory & Medical Writing
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Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

September 27, 2017 – In this webinar, we will discuss 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 will elaborate 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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How to Perform Level C IVIVC in Phoenix

October 31, 2017 – In this webinar, Professor Jean-Michel Cardot will explain 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.

Speaker(s): Jean-Michel Cardot
Solution: PK/PD Modeling & Simulation
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