Using GastroPlus®, PBBM and PKPD to Define Dissolution Safe Space in Support of Registration Specifications

Authors: Mann J, Pepin X, Musser N
Software: GastroPlus®
Division: Simulations Plus

In this webinar, AstraZeneca Principal Scientist James Mann and Simulations Plus Associate Vice President of Regulatory Affairs Xavier Pepin will discuss physiologically based biopharmaceutics models and how they offer a mechanistic way to link in vitro product performance to in vivo exposure. They’ll cover the benefits of PBBM along the drug development timeline, and share a case study on acalabrutinib maleate tablet to illustrate how GastroPlus was used to develop and validate a PBBM, which was used with a PKPD model to define a safe space for the dissolution of the commercial tablets.

If you’re curious how GastroPlus could be used to define dissolution safe space for your own projects, stream now.

James Mann, Principal Scientist of In Vitro Product Performance, AstraZeneca
Xavier Pepin, Associate Vice President, Regulatory Affairs, Simulations Plus

Download Slides

Nate Musser, Director of Alliance Management, Simulations Plus