Bioequivalence and Bioavailability Forum

Dear all
As per the recently published usfda guidance "Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)"

For products manufactured in single-dose units, 30 units each of the test article and
reference standard from each shipment or, for products manufactured in multi-dose units, 3 units each of the test article and reference standard from each shipment, to conduct the necessary testing of the samples.

If we consider approx 20 clinical sites in patient BABE study, considering the guidance for single dose units 30 RLD required as retention quantity for each shipment.


20 sites x 30 single unit= 600 RLD.

The calculated quantity required is very high than the suggested in older guidance i.e. five times all of the release tests.

Is the new published guidance justifies the less requirement of retention quantity? 

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Edit: Guidance linked. [Helmut]