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

posted by yuvaneshwari – India, 2019-04-18 11:12 (1017 d 04:30 ago) – Posting: # 20188
Views: 2,643

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:

Activity
 Admin contact
21,858 posts in 4,574 threads, 1,554 registered users;
online 21 (0 registered, 21 guests [including 19 identified bots]).
Forum time: Saturday 14:43 CET (Europe/Vienna)

Truth in science can be defined as the working hypothesis best suited
to open the way to the next better one.    Konrad Lorenz

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