Not using Bio­strength for BE [Regulatives / Guidelines]

posted by sameep – India, 2018-07-17 08:46 (2167 d 05:32 ago) – Posting: # 19076
Views: 2,562

❝ They have 0.15 mg as highest strength. Can I use 0.15 mg x4 for dosing and biowaive lower strengths?


The product in question needs to be dosed at 0.6 mg for getting measurable concentrations (endogenous substance, baseline correction,...).
Yes, 0.15 mg x 4 tablets can be dosed, Still get a controlled correspondence with FDA.

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