FDA guidance for bioanalytical run [Regulatives / Guidelines]

posted by xiaodongwang – China, 2017-10-23 12:42 (1982 d 20:35 ago) – Posting: # 17907
Views: 2,853

Dear Samar:

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

FDA guidance “Matrix-based standard calibration samples: 75%, or a minimum of six standards, when back-calculated (including ULOQ) should fall within ±15%, except for LLOQ, when it should be ±20% of the nominal value. Values falling outside these limits can be discarded, provided they do not change the established model.

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