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RegisterQCs per run-acceptance criteria [Bioanalytics]
Dear Sir
Please refer to the Bioanalytical Method Validation Guideline -May 2001
Section VI "Application of Validated Method to Routine Analysis"
QC samples in duplicate at 3 concentrations ( LQC, MQC and HQC ) should be arranged in each assay run. What is meant by run, all samples analysed in a day using same Calibration curve, secondly what is meant by duplicate ( 2xLQC, 2xMQC and 2xHQC -duplicate or replicate...?)
Thanks in advance.
Nilima Kalra
Please refer to the Bioanalytical Method Validation Guideline -May 2001
Section VI "Application of Validated Method to Routine Analysis"
QC samples in duplicate at 3 concentrations ( LQC, MQC and HQC ) should be arranged in each assay run. What is meant by run, all samples analysed in a day using same Calibration curve, secondly what is meant by duplicate ( 2xLQC, 2xMQC and 2xHQC -duplicate or replicate...?)
Thanks in advance.
Nilima Kalra
Complete thread:
- QCs per run-acceptance criterianilima 2007-11-20 06:29 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QCs per run-acceptance criteria Helmut 2007-11-20 10:01
- QCs per run-acceptance criteria Ohlbe 2007-11-20 10:07
- QCs per run-acceptance criteria Helmut 2007-11-20 11:42
Ing. Helmut Schütz