Bioequivalence Between two different formulations [Regulatives / Guidelines]

posted by Ohlbe – France, 2016-10-31 12:03 (3527 d 19:41 ago) – Posting: # 16759
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Dear Valiveti,

❝ The study reveals that, the soft gelatin capsule is exhibiting higher concentrations than the hard gelatin capsules


How much higher ? Only Cmax affected, or also AUC ?

❝ Guide me which type of study is required to prove bioequivalence for FDA submission.


Did you check for product-specific recommendations on the FDA website ?
—
Regards
Ohlbe

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