Biowaiver criteria - 5% [Regulatives / Guidelines]

posted by Laura Carreiras – Portugal, 2022-08-12 14:03 (172 d 16:58 ago) – Posting: # 23218
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Hello everyone!


As described in the bioequivalence guideline:

[image]

I would like to know if anyone has experience with a similar situation. If the active substance is equal to 5.00% of the tablet core weight, can it be considered proportional?

Thank you in advance for the help.

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