Is it acceptable to receive innovator product from sponsor in other than market pack?
CHP – Yes, it is OK for the sponsor to supply the innovator product but it is the PI who is responsible to verify that what is presented as an innovator product is actually such a product. You (the CRO) should have an SOP on this situation so the policy is followed uniformly. In any case you would retain samples of both in the event of a regulatory inspection – so it would not be a good idea for the sponsor to play games with this. As a PI, I would want to know how the sponsor came by the product as a way of knowing if it is, indeed, the innovator product. 8. “What is alternative means of treatment” in BA/BE studies? Please clarify. CHP – The term and concept of an “alternative means of treatment” does not apply for BA/BE studies. All you are doing is comparing one product with another which is a copy of the ‘innovator’ agent/drug. There is no issue of “treatment” in a BA/BE study at any time therefore an “alternative treatment” has no meaning.
