Redosing study… [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2011-06-17 15:09 (5491 d 19:02 ago) – Posting: # 7150
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Hello LB,

❝ But that is not the problem of formulation as all others (65 volunteer out of 66) gave normal results in the range of 80-125% TR ratio (with min of 34% and max of 244%) and only one was acting weird.


❝ If such is the case, even after reformulation same volunteer or someone of the same category :crying: could be there to kill your study!!


Yes, this spells trouble. Highly variable drug 'in some patients'. Or highly variable patients among your study population. I think this is where recruitment principles could help you in the future - no guarantees though. I can't imagine a solution in the concrete situation, especially not when non-parametrics are discouraged.

Pass or fail!
ElMaestro

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