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2. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7 on Dissolution Test General Chapter; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2010 Apr 05; 75(64):17148-9. PubMed ID: 20383923 [Abstract] [Full Text] [Related]
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