US FDA published new guidance which describes FDA’s compliance policy related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study.

The guidelines mention Minimum Sample Retention Quantities Sufficient for All Agency Testing.

As per the recent guidance from US FDA, minimum quantity of drug product for sample retention proposed with 30 units each of test and reference product for single-dose units and 3 units each of test and reference product in multi-dose units from each shipment for Investigational Medicinal products.

Weblink for downloading the guidance document:
https://www.fda.gov/media/141218/download

Weblink for the guidance details and to Submit Comments:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-quantity-bioavailability-and-bioequivalence-samples-retained-under-21-cfr-32038c