Is FDA dissolution database more preferable to product specific FDA BE guidance? [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-04-18 11:12  – Posting: # 20188
Views: 1,625

For a Oral solid dosage form [tablet and suspension], FDA dissolution database is recommending dissolution to be done at 25 degrees whereas, product specific FDA guidance for the same product is mentioning 37 degrees.

Which temperature should i need to adapt and follow for generic development ?


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