Dissolution and bracketing (EMA) [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-04-04 08:42 (289 d 03:14 ago) – Posting: # 21315
Views: 1,118

(edited by wienui on 2020-04-04 09:25)

Hi Susan,

» All the General biowaiver criteria are fulfilled except the f2 similarity is not achieved between the highest strength (used in BE study) and the lower strengths

I see from your post above that you had tried to use same dose comparison (2 x 5 mg vs 10 mg), but it didn't help.

» Do I need to do a BE study on all the strengths that are not showing similarity in dissolution

No you don't need if you intended to use the bracketing approach.

What about the similarity in dissolution between the lower strengths for which BE were not conducted, are They similar or there were dissolution differences?

If there are similar between each others, then as you mentioned just perform one BE study for the strength differing most in dissolution with the highest strength (EMA).

In your place I will try to take EMA scientific advice, but you have to keep in mind that any scientific advice or protocol assistance given is not legally binding with regard to any future marketing authorisation application of the product concerned, either on the Agency/CHMP/COMP, or on the Applicant.

Cheers,
Osama

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