The opening post is right about the mechanism and I think understates the practical bit.
My position on specificity is current rather than settled. I have revised it once already and I expect to again, so treat it accordingly.
The opening post is right about the mechanism and I think understates the practical bit.
My position on specificity is current rather than settled. I have revised it once already and I expect to again, so treat it accordingly.
Clear enough that I do not think I have a follow-up, which is unusual.
An independent laboratory's method being different from the supplier's is not a discrepancy. It becomes one only when the results differ by more than both methods' demonstrated precision.
It took me longer than it should have to see that.
A method that reports the same number for every lot is worth a second look. Real processes vary, and a total absence of variation is a statement about the measurement rather than the process.
Following this. I have the same question and no better information than the first post.
Robustness testing deliberately varies the parameters most likely to drift — organic percentage, pH, temperature, flow — and shows the result does not. It is the part of validation that predicts whether a method will transfer.
Read the full topic (49 posts)
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What a stability-indicating method is and how you demonstrate one
Asking directly, because I could not find a straight answer: What a stability-indicating method is and how you demonstrate one Posting a small dataset on stability-indicating method. It is mine, it is…
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4 | 57k | 6mo | |
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Why one laboratory's 98.4% and another's 96.1% may not contradict
Why one laboratory's 98.4% and another's 96.1% may not contradict I have a specific reason for asking rather than idle curiosity, and the context is below. Posting the method first, because I know what the…
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+28 | 37 | 457 | 7mo |
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Specificity, linearity, accuracy, precision, range, robustness — with real criteria — a second dataset
On the subject in the title: Specificity, linearity, accuracy, precision, range, robustness — with real criteria — a second dataset Working notes rather than a conclusion. Posting a small dataset on…
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+53 | 58 | 7.5k | 6mo |
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Revisiting: Spike-and-recover accuracy for a peptide assay
Revisiting: Spike-and-recover accuracy for a peptide assay — setting out what I have, and where I think it stops being reliable. I was wrong about Spike-and-recover accuracy in a thread last spring and I…
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2 | 6.8k | 21h | |
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Coming back to: Specificity, linearity, accuracy, precision, range, robustness — with real criteria
On the subject in the title: Specificity, linearity, accuracy, precision, range, robustness — with real criteria Working notes rather than a conclusion. Trying to establish the boundary conditions on…
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+93 | 99 | 1.4k | 6d |
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Why one laboratory's 98.4% and another's 96.1% may not contradict — one year on
Asking directly, because I could not find a straight answer: Why one laboratory's 98.4% and another's 96.1% may not contradict — one year on Posting the method first, because I know what the first three…
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+10 | 14 | 13k | 5mo |
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Validating a method you did not develop — does this still hold?
Validating a method you did not develop — does this still hold? I have a specific reason for asking rather than idle curiosity, and the context is below. Validating a method, and specifically the version of…
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+128 | 148 | 47k | 16mo |
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Reflectance and photometric devices: precision in practice — a second dataset
Reflectance and photometric devices: precision in practice — a second dataset — setting out what I have, and where I think it stops being reliable. Posting a small dataset on Reflectance and photometric…
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+75 | 82 | 17k | 12h |
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Repeatability versus intermediate precision — what changed since
Posting this under the heading it deserves: Repeatability versus intermediate precision — what changed since Everything below is what sits behind that. What changes if the standard account of Repeatability…
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4 | 21k | 5h | |
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LOD and LOQ: definitions people get wrong
LOD and LOQ: definitions people get wrong — setting out what I have, and where I think it stops being reliable. What changes if the standard account of LOD and LOQ is wrong? I ask because I have been treating…
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2 | 43k | 8mo |