Bioequivalence and Bioavailability Forum

Dear Krishna moorthi

❝ A CRO conducting ba/be study, if they don't perform in-vitro studies, is it

❝ ok to retain twice required quantity for in-vivo study as retention sample.

Not ok, CRO have to retain the quantity required for In vitro as per the guidline

❝ (or should we ask the sponsor how much he needs for one in-vitro test and

❝ retain twice the same at CRO also?)

Of course , get the details from sponsor and ask them to provide the quantity to meet the agency's requirement.

Regards

--
Edit: Full quote removed. Please see this post - and keep the forum's standard quotes (❝ )! [Helmut]