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

posted by jag009  – NJ, 2021-07-06 21:19 (511 d 12:43 ago) – Posting: # 22462
Views: 987

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

Complete thread:

UA Flag
Activity
 Admin contact
22,418 posts in 4,693 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 9 identified bots]).
Forum time: 09:02 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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