Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-11-24 09:42 (61 d 02:24 ago) – Posting: # 22081
Views: 521

(edited by wienui on 2020-11-24 10:09)

Hi Vandee & Ohlbe,

As Ohlbe said, according to EMA for an additional strength biowaiver, the Amount of API(s) must be < 5% of tablet (capsule) core weight for both strengths, the BE strength and the biowaiver one.
Moreover, the Amounts of excipients are the same per strength or Only the amount of a filler is changed to account for changes in API weight.

The FDA doesn't consider this 5% rule and the requirements for an additional strength biowaiver are as following:Both EMA & FDA are asking for the Similarity of dissolution characteristics of the biowaiver strength to the strength for which bioequivalence has been demonstrated in vivo.

I hope this could help.


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