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.
Watch this webinar with C-Path’s Dr. Klaus Romero to learn how they integrated these components into the latest version of the Simcyp Simulator to establish a robust resource that will help development teams and regulators evaluate the safety and efficacy of novel anti-TB drug regimens.
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.
In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.
The scope of Physiologically-based Pharmacokinetic (PBPK) modeling can be expanded by assimilating mechanistic models of intracellular processes from the Systems Biology field. Genome Scale Metabolic Networks (GSMNs) represent whole sets of metabolic enzymes expressed in human tissues. Dynamic models of the gene regulation of key drug metabolism enzymes are also available. Here, we introduce GSMNs and review ongoing work on integrating PBPK, GSMNs and metabolic gene regulation. We demonstrate example models.
In this webinar, Drs. Peter Bonate and Stacey Tannenbaum discuss what kind of technology tools can facilitate a connection with your audience and address the difficulties of speaking into the ether. They offer practical solutions that you can use to strengthen your collaboration in the virtual workplace.