Bioanalytical method validation [Bioanalytics]
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%
% 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]
- Bioanalytical method validationsmrama 2022-05-31 13:41 [Bioanalytics]