Biowaiver for Lower Strength [Regulatives / Guidelines]

posted by vandee – Malaysia, 2020-11-23 06:52 (62 d 07:23 ago) – Posting: # 22076
Views: 631

Dear All,

I'd like to seek some advice regarding a specific requirement in the EMA BE guidelines biowaiver:

the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content

Is this criteria applicable for both the BE strength and the lower strength aimed for biowaiver? 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. All other biowaiver requirements have been met.

Appreciate any advise i can get on this matter. Thank you very much

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