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RegisterFDA guidance for bioanalytical run [Regulatives / Guidelines]
Dear Samar：
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.”
❝ 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.”
Complete thread:
- FDA guidance for bioanalytical run samar sameh 2017-10-22 16:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA guidance for bioanalytical runxiaodongwang 2017-10-23 10:42
- FDA guidance for bioanalytical run Ruba 2017-10-24 09:14
Ing. Helmut Schütz