Bioequivalence and Bioavailability Forum

Dear Anand,

FDA's guidance on pregabalin (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm162465.pdf) clearly states the following for BCS biowaiver route:

It may be possible to request a waiver of in-vivo testing for all the strengths of this product provided that the appropriate documentation regarding high solubility, high permeability and rapid dissolution as detailed in the Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence for Immediate – Release Solid Oral Dosage Forms Based on the Biopharmaceutics Classification System is submitted in the application. You may use information contained in the approved labeling of the reference product. Peer reviewed articles may not contain the necessary details of the testing for the Agency to make a judgment regarding the quality of the studies. A decision regarding the acceptability of the waiver request can only be made upon review of the data submitted in the application.

Essentially if data submitted satisfies the FDA requirement, it could be fine.

Kind regards,
Tina