Bioequivalence and Bioavailability Forum

Hi Helmut and ElMaestro,

Thanks a lot for your answers and your comments.

I totally agreed with all you said about protocol deviation and the ethics concern. Rights, safety and well-being of the study subjects is all that matters and all that we must worry about.

Just for you to know, finally we contacted the PI. His explanation for using parenteral hydration was related to the sample collection. Specifically, to keep the permeability of the intravenous route. That it was a normal procedure for them and it´s described in the site´s sops. I have never heard or read something like this! 1000 – 2500 ml of solution for that! ........

Best regards,

CEC75