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RegisterOnly for QCs; encouraged ≠ required [Bioanalytics]
Hi Helmut!
As per standard SOP - "If the response of internal standard in a sample varies by more than 60% for the isotopically labeled internal standard from the mean ISTD response of CC and QC samples of a particular entire run, then repeat the analysis of the sample under reason Significant variations in response of internal standard"
However - there is no guideline which specifies the limit for variation for IS. Thus, it could be 30/40/50/60 - as per CRO's SOP/requirement/Experience.
The interesting thing could be - whether the QC's analyte/IS standard response are within acceptable range - i.e. whether the QC's were acceptable? if the IS standards response are high, there is possibilities that the QC will be on lower side. I am wondering what other things can be directly correlated and what can be the reason for CRO's acceptability of variation in IS response?
Regards,
Dshah
As per standard SOP - "If the response of internal standard in a sample varies by more than 60% for the isotopically labeled internal standard from the mean ISTD response of CC and QC samples of a particular entire run, then repeat the analysis of the sample under reason Significant variations in response of internal standard"
However - there is no guideline which specifies the limit for variation for IS. Thus, it could be 30/40/50/60 - as per CRO's SOP/requirement/Experience.
The interesting thing could be - whether the QC's analyte/IS standard response are within acceptable range - i.e. whether the QC's were acceptable? if the IS standards response are high, there is possibilities that the QC will be on lower side. I am wondering what other things can be directly correlated and what can be the reason for CRO's acceptability of variation in IS response?
Regards,
Dshah
Complete thread:
- An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
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- An example of IS response. Need your helps. Ohlbe 2020-05-26 14:42
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- An example of IS response. Ohlbe 2020-05-26 17:27
- Placement of CC Ohlbe 2020-05-26 17:32
- Placement of CC Helmut 2020-05-26 19:03
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Duplicate LLOQ and ULOQ Helmut 2020-05-27 16:30
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Placement of CC Helmut 2020-05-26 19:03
- An example of IS response. Shuanghe 2020-05-26 16:32
- Placement of CC Helmut 2020-05-26 15:35
- An example of IS response. Need your helps. ElMaestro 2020-05-26 15:44
- An example of IS response. Need your helps. ksreekanth 2020-07-06 13:37
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- Broken-stick regression Helmut 2020-08-04 18:04
- Only for QCs; encouraged ≠ requireddshah 2020-08-03 09:17
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
Ing. Helmut Schütz