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FDA Guidelines for Dissolution

Please share the list of FDA guidelines on Dissolution. Where dissolution method development, validation and specification setting procedure covered.

FDA guidelines on Dissolution:

  1. Dissolution Testing of Immediate Release Solid Oral Dosage Forms
  2. Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form
  3. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

 

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