Bioequivalence and Bioavailability Forum • Is FDA dissolution database more preferable to product specific FDA BE guidance?

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

posted by yuvaneshwari – India, 2019-04-18 11:12 (914 d 11:33 ago) – Posting: # 20188
Views: 2,563

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 ?

Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

Is FDA dissolution database more preferable to product specific FDA BE guidance?yuvaneshwari 2019-04-18 11:12 [Dissolution / BCS / IVIVC]
- Is FDA dissolution database more preferable to product specific FDA BE guidance? Vineeth KE 2019-04-25 13:15