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

posted by yuvaneshwari – India, 2019-04-18 13:12 (1806 d 05:10 ago) – Posting: # 20188
Views: 3,444

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
78 visitors (0 registered, 78 guests [including 8 identified bots]).
Forum time: 17:22 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5