change in CC range [Regulatives / Guidelines]
As per applicable method validation, validated CC range for Analyte X is 10.0 ng/ml to 11015.9 ng/ml, 15.1 ng/ml to 6037.2 ng/ml for Y Analyte and 0.20 ng/ml to 9.84 ng/ml for Z Analyte however during subject sample analysis CC range used is 10.0 ng/ml to 11031.0 ng/ml, 15.1 ng/ml to 6039.8 ng/ml and 0.20 ng/ml to 9.96 ng/ml for X, Y and Z respectively which is outside the validated CC range.
I just wanted to confirm whether this is acceptable or not? also wanted to know is there any acceptable % deviation mentioned in any guideline related to change in CC range which found during method validation and subject sample analysis.
Edit: Please follow the Forum’s Policy. [Helmut]
I just wanted to confirm whether this is acceptable or not? also wanted to know is there any acceptable % deviation mentioned in any guideline related to change in CC range which found during method validation and subject sample analysis.
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- change in CC rangesushil.pimpare 2017-05-31 09:31
- exact matching of CCs (validation’s and study’s) Helmut 2017-05-31 12:41
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s) ElMaestro 2017-05-31 14:11
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 15:38
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 13:46
- Sapere aude! Helmut 2017-05-31 14:46
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s) Helmut 2017-05-31 12:41