Science & Risk Based Stability Practices in Pharmaceutical Development Webinar: Part I
Science & Risk Based Stability Practices in Pharmaceutical Development Part I: Application of Science RBPS to Small Molecules
Thu, Feb 3, 2022 11:00 AM - 12:00 PM EST
Presented by Science and Risk Based Predictive Stability Working Group
Sponsored by Analytical Leadership Group
- Brian Regler, Boehringer Ingelheim
- Russell Hertzler, AbbVie
Health agencies require sponsor companies to understand the stability of their products as thoroughly as possible at the time of market authorization. In order to accomplish this, stability knowledge is gathered and accrued throughout development from a number of different studies that help us understand how the product will behave during usage and long-term storage.
The following learning points will be discussed:
- Introduce the concept of a stability life cycle throughout product development
- Various predictive stability models for small molecules
- Risk mitigation strategies for leveraging accelerated predictive stability approaches
- Conducting forced degradation studies, excipient compatibility studies and using Zeneth during development
This webinar is open to the general public. Membership in the IQ Consortium is not required for registration.