Not using Bio­strength for BE [Regulatives / Guidelines]

posted by zheng791 – US, 2018-07-13 21:31 (800 d 00:00 ago) – Posting: # 19052
Views: 2,152

Our firm is developing a multi-strength product which is a high potency, NTI oral dosage. The highest strength is 0.3 mg. The product guidance requests to use 0.3 mg x2 tablets for dosing and biowaive the lower strengths. However, our firm does not want to develop 0.3 mg. They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths? These strengths are similarly proportional, that is have the same tablet weight, the filler weight changes to compensate the API change.

Thank you

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