USP Emerging Standards & Iterative Approaches to Novel Excipient Development
Time: 2:00 pm
day: Conference Day Two
Details:
- Analyze the regulatory and safety assessment challenges that limit the use of novel excipients, focusing on implications for early-phase drug development
- Explore USP’s initiatives to advance novel excipient development, including the creation of Novel Excipients Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines
- Gain insights into USP’s iterative approaches and emerging standards for novel excipient standard development and stakeholder engagement, highlighting their role in addressing evolving quality needs in pharmaceutical development
NEW COMPANY
