Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-11-23 11:41 (1684 d 08:18 ago) – Posting: # 22077
Views: 3,090

Dear vandee,

❝ Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.


The 5% criterion applies to both strengths, lower and higher.
—
Regards
Ohlbe

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