Bioanalytical method validation [Bioanalytics]

posted by smrama – India, 2022-05-31 15:41 (250 d 12:47 ago) – Posting: # 23032
Views: 995

Hi all,
This forum has been a good guidance to me, to most of my queries and has been helpful to decide the uncertain situations.

But there is situation which currently I needed some guidance with and below are the details,

In long-term stability experiment, only one out of six LQC was within 85-115%
      % Bias
QC1   +16.99
QC2   +19.44
QC3   -15.59
QC4   -27.04
QC5    +1.21
QC6   +16.90
% CV   19.13
% Bias  1.99

The %CV at LQC was not within 15%. Still, the results were accepted since the % bias was within 15%.

The analytical investigator said that the results can be accepted as per in-house sop, and the “Bioanalytical Method Validation Guidance for Industry” of USFDA and “Guideline on bioanalytical method validation” of EMA if the accuracy (% nominal) at each level be ± 15%.

Please clarify if this approach is acceptable.

Edit: Tabulators changed to spaces and BBcoded; see also this post #6[Helmut]

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