BLQ handling in BE study where all values in one profile are BLQ [NCA / SHAM]

posted by Ibrahim Komeil – Egypt, 2019-11-28 14:55  – Posting: # 20889
Views: 208

Hi Simon

I think that we will face a problem in optimization the linearity for this volunteer and weighing the calibration curve, i think that you can't modify the bioanalytical validation for single volunteer. But you can do it for all volunteers not for one person only by changing in LLOQ

Regards,


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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