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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%
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]
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 1.99The %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]
Complete thread:
- Bioanalytical method validationsmrama 2022-05-31 13:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioanalytical method validation Ohlbe 2022-05-31 19:30
- Bioanalytical method validation qualityassurance 2022-06-01 11:47
- Bioanalytical method validation Ohlbe 2022-06-01 13:14
- Bioanalytical method validation smrama 2022-06-02 12:50
- Bioanalytical method validation smrama 2022-06-02 12:51
- Bioanalytical method validation Ohlbe 2022-06-01 13:14
Ing. Helmut Schütz