Quality by Design [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2011-07-01 14:47 (5460 d 12:00 ago) – Posting: # 7197
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Dear all,

following a today’s presentation by Andre S. Raw (FDA, OGD, Acting Deputy Director Division of Chemistry I) have fun with this document: Quality by Design for ANDAs: An Example for Modified Release Dosage Forms (102 pages, 1.63 MB).

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