The Chinese Pharmacopeia (ChP) has different requirements for dissolution testing than the US Pharmacopeia (USP), the European Pharmacopeia (EP), and the Japanese Pharmacopeia (JP), including:
- 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 when a company plans to release product in China.
This session will cover best practices, science-based approaches, and a rationale of ChP requirements. We will also discuss strategies for partnering with our ChP colleagues to achieve quality, efficient, science-based approaches to meet our patient needs.
This session will also provide a forum to increase awareness and partnership with our global colleagues. We will provide an opportunity to share preliminary survey findings on this issue as well as hear your feedback and concerns.
- Become aware of ChP requirements
- Learn how to address these requirements
- Develop dissolution design strategy
- Establish a forum to discuss such issues
- Enhance international harmonization
Mark Alasandro, Ph.D., MZA Pharmaceutical Consulting
Vivian Gray, Ph.D., V. A. Gray Consulting, Inc.
Bing Gu, Ph.D., Vertex
Xujin Lu, Ph.D, Bristol Myers Squibb
Yan Wu, Ph.D., University of North Carolina