Biowaiver criterion <5% (not ≤5%) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-08-12 14:17 (225 d 08:31 ago) – Posting: # 23219
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Hi Laura,


❝ 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?

Do you have rounding here, say, 5.0049% → 5.00%?
Even if not, ‘less than’ ‘less or equal than’…

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