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: 346

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,486 posts in 4,135 threads, 1,334 registered users;
online 15 (0 registered, 15 guests [including 11 identified bots]).
Forum time (Europe/Vienna): 03:02 CEST

If debugging is the process of removing bugs,
then programming must be the process of putting them in.    Edsger W. Dijkstra

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5