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