Bioequivalence and Bioavailability Forum

Hi Obi,

❝ Please let me know where I'm missing it...cos I feel I'm missing something.

Those are very valid thoughts.
In BE the tradition is to have analysts blinded wrt treatment, so they know subject and period and time point but not randomisation and therefore they can't say if subject 3 in period 1 got treatment T or R. They will not be able to tell the T/R for any subject. And therefore they cannot easily manipulate it.

Blinding wrt time point would be interesting. It may be the solution to a non-existing problem, though? You mean they could use that info to create smooth profiles that more or less correspond to the expectation in terms of e.g. t half etc? I'd say that is theoretically correct, they could do that.

History has shown that if you really keep the randomisation code under lock and key then the chance to manipulate a trial is lower than if you don't. Conversely the PI in a BE trial needs not be blinded because she/he cannot easily manipulate the trial result. If the PI were scoring e.g. wound healing visually in a PD trial then she/he would often need to be blinded.