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

posted by bharathi – India, 2019-09-26 14:20 (1839 d 18:02 ago) – Posting: # 20649
Views: 3,661

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
23,249 posts in 4,885 threads, 1,653 registered users;
45 visitors (0 registered, 45 guests [including 3 identified bots]).
Forum time: 08:22 CEST (Europe/Vienna)

I have never in my life learned anything
from any man who agreed with me.    Dudley Field Malone

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