Exclusion of anchor points in LBA [Bioanalytics]

posted by manojbob – India, 2020-07-03 14:31 (116 d 22:11 ago) – Posting: # 21643
Views: 1,428

Guidelines do not provide any criterion for acceptance of anchor points and it is understood because these point are not part of valid calibration range. I wish to seek your suggestion on exclusion of anchors. This query is for method validation as well as routine analysis.
SDT-01 is anchor and STD-02 is LLOQ of the curve - given a situation
1) when the OD of STD-01 is equal to or greater than that of STD-02 and all standards of the curve meet acceptance criteria, can we choose to mask the lower anchor since we know that the OD is higher.
2) The STD-02 of the curve does not meet criteria and when the lower anchor is masked the same would fall within criteria. in such case can the lower anchor be masked and can this be termed as improvement in curve fit.
3) The method is validated and established with anchors and during routine analysis If the lower anchor is masked for any reason, then since anchor point is included in regression formula for 4 or 5 PL, would the next point i.e. STD-02 (LLOQ) be considered as new anchor and in such case would the curve be accepted.

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