Bioequivalence and Bioavailability Forum

Hi guys,

I have been thinking....please help me out lest I drown in my thoughts.

What's the relevance of treatment blinding of the bioanalyst if he analyses all the samples of each subject in one single run. I feel it's irrelevant that he is blinded cos he knows that all samples for a subject (for both treatments in period 1 and 2) will be analyzed in a single run.

I think the best form of blinding would be blinding of the sampling time points within each period. This way, the analyst wouldn't be biased into ensuring the results follow the single compartment PK model. The concern of carryover effect if detected during the bioanalytical method validation can be taken care of by the injection of blank samples.

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

Regards,