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.
Presenters:
James Mann, Principal Scientist of In Vitro Product Performance, AstraZeneca
Xavier Pepin, Associate Vice President, Regulatory Affairs, Simulations Plus
Moderator:
Nate Musser, Director of Alliance Management, Simulations Plus