bharathi
☆    

India,
2019-09-26 12:20

Posting: # 20649
Views: 1,698
 

 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
jag009
★★★

NJ,
2019-10-22 21:29

@ bharathi
Posting: # 20714
Views: 690
 

 12 units from 12 different bottles should be used - Dissolution for Suspensions

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"?

Please cite reference for the 2nd recommendation.

J
Activity
 Admin contact
20,345 posts in 4,273 threads, 1,402 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 23:34 CET

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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