biowaiver for higher strength [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2022-02-01 10:12 (305 d 19:43 ago) – Posting: # 22768
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(edited by wienui on 2022-02-01 15:29)

Hi John,

❝ Based on the above, can I file a biowaiver for the higher strength test product so I don't have to run a PK BE study?


Are both strengths (low & high) follow the following EMA 5% & exceients rule?

EMA :
Amount of API must be < 5% of tablet core weight, and
Amounts of excipients are same per strength, or
Only the amount of a filler is changed to account for changes in API weight.

Cheers,
Osama

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