USP heard you! We recognize that our current approach of adding additional monograph dissolution tests when an FDA-approved manufacturer cannot meet the existing testing requirements has resulted in the proliferation of methods in our standards, particularly for extended-release dosage forms. We understand that this proliferation in USP monographs is not ideal. We are, therefore, seeking input on alternate approaches to multiple dissolution tests in individual monographs.
Please join us on November 07, 2024, from 9:00 AM to 12:00 PM EST for the first of a series of events to brainstorm alternative approach(es) that can be implemented to help meet regulatory requirements and stakeholder expectations.
Tentative Agenda:
- Background on the inclusion of multiple dissolution tests in monographs
- Evolution of dissolution test inclusion
- Advantages and disadvantages to stakeholders
- USP and stakeholder perspectives
- Brainstorming session: What potential alternative approaches could USP employ to create monographs that would still help ensure article quality and provide stakeholders with necessary information
- Conclusion and next steps
Note: this is a hybrid event (capped at 40 in-person attendee)
If you have any further questions, please contact SEPC@usp.org