FDA guidance for bioanalytical run [Regulatives / Guidelines]

posted by Ruba – Jordan, 2017-10-24 11:14 (1980 d 06:58 ago) – Posting: # 17910
Views: 2,744

❝ Does this apply for FDA submissin, meaning:can we exclude the ULOQ and the LLOQ from calibration range ?

Dear Samar

i think as per FDA guideline; it is allowed to exclude Upper limit of quantitation BUT not LLOQ. below is FDA quote

The acceptance criterion for the standard curve is that at least 75% of non-zero standards should meet the above criteria, including the LLOQ. Excluding an individual standard should not change the model used. Exclusion of calibrators for reasons other than failing to meet acceptance criteria and assignable causes is discouraged.

i am not sure if other Colleagues has other views :-)

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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