bharathi
☆    

India,
2019-09-26 12:20

Posting: # 20649
Views: 898
 

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

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
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,885 posts in 4,214 threads, 1,366 registered users;
online 6 (0 registered, 6 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 01:38 CEST

The real purpose of the scientific method is to make sure
nature hasn’t misled you into thinking you know something
you actually don’t know.    Robert M. Pirsig

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