Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-11-23 10:41 (53 d 19:44 ago) – Posting: # 22077
Views: 525

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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