Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn’t good for your health. But, did you know that smoking can affect the metabolism of other drugs and even cause serious drug interactions? In this blog post, I’ll discuss the mechanisms by which smoking can impact pharmacokinetics, how physiologically-based pharmacokinetic … Continued

Using PBPK Models to Optimize Antiviral Dosing at the Point of Care

The use of physiologically-based pharmacokinetic (PBPK) modeling for drug development is well-established and is now routinely used by the pharmaceutical industry, regulators, and researchers. In this blog post, I’ll discuss a novel application that combined PBPK and Bayesian modeling to help clinicians optimize dosing at the point of patient care. This application was used to … Continued

Leveraging Phoenix for Dissolution Testing to Meet Regulatory Guidelines

During this presentation, Jean-Michel Cardot, professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Auvergne University in France, discussed the tools available to formulation scientists performing dissolution testing and what regulatory guidelines must be considered when performing these tests.

Get Ready for CDISC SEND

In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance.

Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?

A Streamlined Approach to Policy 70

David Cornwell, Founder and CEO of PleaseTech and Lora Killian, Synchrogenix Director of Transparency and Disclosure, provided an in-depth review of the full streamlined process created as a result of the partnership between Synchrogenix and PleaseTech.