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