Bioequivalence and Bioavailability Forum • Bracketing approach for multiple strenght product EMA

jag009
★★★

NJ,
2021-07-06 21:19
(1355 d 09:23 ago)

Posting: # 22462
Views: 2,472

Bracketing approach for multiple strenght product EMA [Regulatives / Guidelines]

Hi all,

For drug product which have multiple strengths (lets say 3), my thinking is to run a BE study comparing highest and lowest strength, and present dissolution similarities between the three strengths + a formulation composition table showing that the formulations are proportional.

Question: What if the product release > 85% within 15 mins? If so then one can't use dissolution to demonstrate similarity.

The product is BCS class 2.

Thx

J

dshah ★★ India, 2021-07-17 13:44 (1344 d 16:57 ago) @ jag009 Posting: # 22474 Views: 1,888	Bracketing approach for multiple strenght product EMA Post reply
	Dear J! If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied. Regards, Dshah