PK_Lover
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Portugal,
2013-02-28 13:54
(4864 d 09:56 ago)

Posting: # 10129
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 Bracketing Approach and Biowaivers [Dissolution / BCS / IVIVC]

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Hello there,

I have a doubt regarding the application of the EMA Guideline on Bioequivalence.

If I need to use a bracketing approach for a generic application of 5 different strenghts (eg: 1, 2, 4, 8 and 10 mg) and I choose the extreme ones to conduct 2 in vivo BE studies (1 and 10 mg).

How should I handle the biowaiver of the remaining strenghts regarding the in vitro dissolution profiles? Should these strenghts show similarity with both the BE strenghts (1 and 10 mg) or with just one (for example the higher one)?

Thank you very much for your help since I could not find any answers on the BE guideline document.

Kind Regards.
PK_Lover

Edit: Category changed. [Helmut]
 
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