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RegisterReporting QCs [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2007-08-30 14:05 (6872 d 04:10 ago) – Posting: # 1041
Views: 8,846
Dear Harish!
Good idea - would be possible for n>6 anyway, which in validation generally is performed only for LLOQ-samples.
Yes, you should include all measured values in the report (your method's specifications should be transparent).
Excluded values should be flagged (i.e., by means of an asterisk leading to a footnote, orstriken through).
I would suggest to present two tables for Accuracy/Precision; one with and the other one without excluded values - making the life of auditors and regulatory inspectors less miserable.
See also this thread.
P.S. I changed your user name from capitals only to mixed-case.
❝ Let's first assume that we are not performing any outlier test.
Good idea - would be possible for n>6 anyway, which in validation generally is performed only for LLOQ-samples.
❝ During Bioanalytical Method Validation, do we need to include the failed
❝ QCs in the Inter & Intra batch summary table for Mean & CV%
❝ calculations?
Yes, you should include all measured values in the report (your method's specifications should be transparent).
Excluded values should be flagged (i.e., by means of an asterisk leading to a footnote, or
I would suggest to present two tables for Accuracy/Precision; one with and the other one without excluded values - making the life of auditors and regulatory inspectors less miserable.
See also this thread.
P.S. I changed your user name from capitals only to mixed-case.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Reporting Failed QCs Dr. Harish L. Rao 2007-08-30 08:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reporting QCsHelmut 2007-08-30 12:05
- Reporting QCs Ohlbe 2007-08-31 10:46
- Reporting QCs Charl 2007-09-02 15:11
- Reporting QCs Ohlbe 2007-09-02 23:50
- Reporting QCs Charl 2007-09-03 10:13
- Precision of incurred samples Ohlbe 2007-09-03 10:20
- Problematic incurred samples guidelines Helmut 2007-09-03 19:49
- Precision of incurred samples Ohlbe 2007-09-03 10:20
- Reporting QCs Charl 2007-09-03 10:13
- Reporting QCs Ohlbe 2007-09-02 23:50
- Reporting QCs Charl 2007-09-02 15:11
- Reporting QCs Ohlbe 2007-08-31 10:46
- Reporting QCsHelmut 2007-08-30 12:05
Ing. Helmut Schütz