Bioequivalence and Bioavailability Forum

Dear Sonu
I guess the studies are to be conducted according to FDA regulation for an ANDA application, right? In this case where a CRO with multiple testing facilities conducts more than one BE study (e.g., fed and fasted studies) for the same drug product, and the study test article and reference standard are sent to the testing facilities in different shipments, the FDA recommends that sufficient quantity of reserve samples be kept for each study at each testing facility. These approaches are to ensure that the reserve samples are in fact representative of the batch provided by the study sponsor and/or drug manufacturer to the testing facility.
I hope this helps.
Kind regards
Dr_Dan