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

posted by bharathi – India, 2019-09-26 12:20 (572 d 14:58 ago) – Posting: # 20649
Views: 2,624

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:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time: Wednesday 03:18 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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