Bioequivalence and Bioavailability Forum

❝ In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.

Dear luvblooms,

Can you just mentioned the few probable reasons for not accepting the published literature information? If the Clinical Pharmacology and biopharmaceutics data of Innovator clearly demonstrated a validated permeability study conducted using all the standards (low permeable, moderate permeable, high permeable, zero permeable) will it be acceptable in your opinion?

Thank You in advance!
Maitri

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]