Bioequivalence and Bioavailability Forum

Dear wienui,

❝ First of all, I wish you a happy successful new 2020.

Thanks and the same to you.

❝ I face a situation for the first time, during evaluation of a BE study for a formulation which should be performed in fasting and fed conditions. both studies conducted in the same starting and ending period dates, till the moment I don't have something against that, but what makes me very worry is that both study were conducted in the same clinical site and both have the same principle investigator !!!

❝

❝ Is there any GCP Guidelines which regulate ( allowed or prohibited) this issue?

Is this an issue at all?
It is entirely common that the PI is one and the same for all studies at a given CRO or clinic, regardless of whether studies are conducted serially or concomitantly.
At the end of the day the PI has overall responsibility and the delegation log (and training and ...) is the key to making sure the PI is not over-worked.

In some countries the PI is purely an administrative matter; she or he will not see the subjects/patients but have everything delegated. These studies, including their formal setup, are OK to local authorities as well as to FDA, EMA/EU, TGA, PMDA, WHO, HC and more.