Organizer: IVRDT Community (Xujin Lu, Vivian Gray, Bing Gu)
Stability Community (Mark Alasandro, Yan Wu)
Title: Dissolution Best Practices and International Harmonization
Timing: August 16, 2022
Description – Why attend this talk
Chinese pharmacopeia (CHP) has different requirements for dissolution testing compared to USP/EP/JP, such as:
- Testing approach and passing criteria for different stages is different, CHP requires a Q=85% while US is typically 80%
- Interpretation of the "Q" term for certain dosage forms is different
- No more than 12 dosage forms can be investigated.
These differences can cause considerable retooling of methods and specifications, as a company plans to release product in China.
This Workshop will cover these harmonization issues along with best practices, science-based approaches, and emerging and current equipment and apparatus issues.
This session will also provide a forum to increase awareness and partnership with our global colleagues.
Learning Objectives:
- Awareness of CHP requirements
- How to address these requirements
- Explore the best practices in developing dissolution design strategy
- Explore equipment and apparatus challenges
- Enhance international harmonization
- Setting industry best practice