On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
The domestic guidelines for individual drugs specify dissolution profile studies, that should be performed with reference, and the unspecified parts of individual drug guidelines can be performed with reference to this.
This Q&A Mainly answers the following questions:
How to select:
- Dissolution medium,
- Rotation speed,
- Sampling points of dissolution profiles
How to conduct comparative studies of :
- dissolution profiles of different strengths
- dissolution profiles of sustained and controlled-release preparations
- dissolution profiles of enteric-coated preparations.
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