bharathi
☆    

India,
2019-09-26 14:20
(2107 d 18:56 ago)

Posting: # 20649
Views: 4,184
 

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

Post reply
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 23:29
(2081 d 09:47 ago)

@ bharathi
Posting: # 20714
Views: 2,649
 

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

Post reply
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
 
UA Flag
Activity
 Admin contact
23,426 posts in 4,929 threads, 1,679 registered users;
73 visitors (1 registered, 72 guests [including 43 identified bots]).
Forum time: 09:17 CEST (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

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