Korean MFSD publishes Revision 7 of Comparative Dissolution Test Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test (Guideline for Civil Petitioners)". A new version (revision 7) dated 18 May 2023 was published.

The document is divided into the following main chapters:

  • Overview
  • Considerations when Determining the Equivalence of Comparative Dissolution Test Data
  • Comparative Dissolution Test Result Report Standard Format
  • References

According to the English translation of chapter 1, "the purpose of this guideline is to help applicants or reviewers understand as reference data for preparation of comparative dissolution test result reports required when applying for pharmaceutical product approval/notification (including changes). [...] This guideline is applied to items subject to comparative dissolution testing for new items for approval and notification of pharmaceuticals and items with changes in approval items."

Compared to the previous version, which was published in 2021, the new document contains additional considerations and references when determining equivalence of comparative dissolution test.

The revised guideline in Korean language can be found as a PDF file on the website of the Ministry of Food and Drug Safety.

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