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What is International Harmonization in Dissolution about?

This document summarizes a workshop on dissolution best practices and international harmonization. There are differences between pharmacopeias like the USP, EP, JP, and ChP in terms of dissolution testing requirements and acceptance criteria. For example, the ChP definition of Q differs from the USP, has only two testing stages compared to three in USP/ICH, and allows testing of fewer units. The workshop aimed to increase awareness of these differences and discuss strategies to address them in order to deve

Author

Ehab Adel

Language

EN