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.
Learn how non-parametric approaches can be used to determine time scaling for in vitro-in vivo correlation (IVIVC).
This webinar described how the Simcyp pregnancy-PBPK model was used to predict systemic exposure during pregnancy for two probe medications: tacrolimus and oseltamivir.
D360 makes it easy for all project team members to access standard discovery project data views or perform exploratory analyses. This webinar focuses on utilizing D360 to get the most out of drug discovery data by utilizing simple query-building with integrated chemistry tools and analysis tools, dynamically linked data visualizations and easy to use annotations. […]
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
During this presentation, Lora Killian, Synchrogenix Director of Transparency and Disclosure, discussed complications caused by the requirements outlined in the guidance document, EMA Policy 70, and proposed some solutions.
A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners
Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the Sponsor or research center after the last study visit, leaving many volunteers wondering if their participation was valued or appreciated. Over the past five years, the nonprofit Center […]