FDA: Diss. and Spec’s for BCS Classes 1 and 3 [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2015-09-14 13:52 (3438 d 15:41 ago) – Posting: # 15395
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Dear all,

the FDA published a new Draft Guidance “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs”. In a nut­shell:

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