12 units from 12 different bottles should be used - Dissolution for Suspensions [Regulatives / Guidelines]

posted by bharathi – India, 2019-09-26 14:20 (1696 d 22:40 ago) – Posting: # 20649
Views: 3,307

Hi,

I wonder why some of the USFDA BE recommendations has "Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products" and other specify as "A total of 12 units from 12 different bottles should be used"?

What is the criteria for 2 different statements for suspensions

Regards,
Bharathi

Complete thread:

UA Flag
Activity
 Admin contact
23,029 posts in 4,834 threads, 1,644 registered users;
28 visitors (0 registered, 28 guests [including 5 identified bots]).
Forum time: 13:00 CEST (Europe/Vienna)

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

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