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

posted by jag009  – NJ, 2021-07-06 19:19 (356 d 10:18 ago) – Posting: # 22462
Views: 886

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

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