Baseline correction or supra-thera­peu­tic dose [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-09-16 19:55 (3537 d 00:50 ago) – Posting: # 15409
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Dear Helmut,

❝ first of all I agree with Lucas. I don’t get the idea of basing BE on uncorrected data.


I can see one theoretical situation which could be tricky. I don't know whether you have come across anything like this.

Many endogeneous compounds follow a circadian rythm. What if the concentrations at 8 AM are higher than in the evening ? Negative concentrations after baseline correction will be replaced with 0. Couldn't this artificially decrease the difference between formulations, compared with a non-baseline-corrected analysis ? I mean, if formulation A gives concentrations 50 % lower than formulation B, both negative after baseline correction and reset to 0...

Regards
Ohlbe

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