Dissolution Best Practices and International Harmonization

When:  Aug 16, 2022 from 09:00 to 17:00 (ET)
Associated with  Stability Community

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: 

  1. Testing approach and passing criteria for different stages is different, CHP requires a Q=85% while US is typically 80%
  2. Interpretation of the "Q" term for certain dosage forms is different
  3. 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:

  1. Awareness of CHP requirements
  2. How to address these requirements
  3. Explore the best practices in developing dissolution design strategy
  4. Explore equipment and apparatus challenges
  5. Enhance international harmonization
  6. Setting industry best practice
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