Cherry-picking [Study Assessment]
❝ I thought that something like clinical pharmacology of the drug may, to some extent, reassure our NCA that safety and efficacy are not at risk?
OK, you missed the lower limit of Cmax for one API. It depends on the drug whether this imposes a risk to the patients. Efficacy is in many cases more related to AUC than to Cmax. Exceptions are f.i. painkillers where Cmax (and tmax!) is important. Safety is generally related to the upper limit of Cmax.
Now for the big but: If you consider the conventional limits of 80–125% Cmax being too strict, you should have stated wider limits (or aim at reference-scaling in a replicate design if CVwR >30%) already in the protocol and discussed that with the agency before performing the study.
It smells of cherry-picking if you fail to show BE according to the protocol and afterwards about a patient’s risk which you consider not relevant for any reason.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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