Bioequivalence and Bioavailability Forum

Hi both,

❝ ❝ Analyst is always blind …

❝

❝ Analytics would be a tough job for a blind analyst.

❝ You mean blinded for treatment.

Ah, the necessary continuation of last week's game of words.

❝ ❝ By keeping different sampling time points i.e. 20 time-points for test and 22 time points for reference, whether analyst will blind in this condition?

❝

❝ Of course, not (assuming that he/she is not stupid). Sometimes you aim at different sampling times (say when comparing MR to IR, DR to IR, IR to IV or an solution) in order to have an optimal schedule describing the profiles.

❝ Keep the number of time points equal and give the sequence of samples (1, 2, …, n) and not the time points themselves (t₁, t₂, …, t_n) on the vials’ label.

It is an interesting situation though. There is quite some focus on blinding at the moment. I guess one could pad the series holding only 20 samples with a sample 21 and 22 based on extracted un-spiked plasma. That would kind of win the olympic gold, wouldn't it? The analyst will presumably be able to tell nothing about the nature of samples due to just the number of samples per series (or to say it diffrently: the CRO has done what it can to avoid situations when she/he can).

I would love to see this done in practice.