Bioequivalence and Bioavailability Forum • 12 units from 12 different bottles should be used

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

posted by bharathi – India, 2019-09-26 14:20 (2065 d 09:45 ago) – Posting: # 20649
Views: 4,121

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:

12 units from 12 different bottles should be used - Dissolution for Suspensionsbharathi 2019-09-26 12:20 [Regulatives / Guidelines]
- 12 units from 12 different bottles should be used - Dissolution for Suspensions jag009 2019-10-22 21:29