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 jag009 – NJ, 2019-10-22 23:29 (2035 d 23:34 ago) – Posting: # 20714
Views: 2,596

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

Complete thread:

12 units from 12 different bottles should be used - Dissolution for Suspensions bharathi 2019-09-26 12:20 [Regulatives / Guidelines]
- 12 units from 12 different bottles should be used - Dissolution for Suspensionsjag009 2019-10-22 21:29