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

posted by yuvaneshwari – India, 2019-04-18 11:12 (521 d 08:22 ago) – Posting: # 20188
Views: 1,937

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
21,068 posts in 4,392 threads, 1,465 registered users;
online 16 (0 registered, 16 guests [including 7 identified bots]).
Forum time: Sunday 19:34 CEST (Europe/Vienna)

Data is not information.
Information is not knowledge.
And knowledge is certainly not wisdom.    Clifford Stoll

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