Bioequivalence and Bioavailability Forum

Dear Sonu,

I think the rule is clear: you have to keep the required amount of test articles at each CRO.

Remember that the idea behind that requirement is not just to check that the IP pass the release tests. The idea is also to be able to check the identity of the products used and to make it more difficult to run the BE as reference vs. reference by labelling some reference IP as test, as found in the generic drug scandal in the USA in the early '80s. Therefore retention IPs need to be kept at each trial site.