avinash ★ India, 2023-06-30 11:28 (520 d 10:50 ago) Posting: # 23636 Views: 3,221 |
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Dear Members This is with regard to ICH M10 guideline Under section, “Accuracy and Precision”, for non-accuracy and precision validation runs, low, medium and high QCs may be analysed in duplicate. These QCs, along with the calibration standards, will provide the basis for the acceptance or rejection of the run. Here does non-accuracy and precision validation runs means all other runs except accuracy and precision runs, which includes selectivity, specificity, matrix effect, carry-over, dilution integrity, stability and reinjection reproducibility? Please help me to understand what is non-accuracy and precision validation runs? Thanks & regards, Avinash Edit: Guideline / Section linked. [Helmut] |
Helmut ★★★ Vienna, Austria, 2023-06-30 13:33 (520 d 08:44 ago) @ avinash Posting: # 23637 Views: 2,700 |
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Hi Avinash, not answering you question but a general comment. IMHO, the confusion in terminology (also in other bioanalytical guidelines) is probably caused by only a few analytical chemists (for ICH M10 just one?) involved.* Accuracy is qualitative. We want that our result have small inaccuracy (which is quantitative). The ±15% (±20% at the LLOQ) ‘accuracy‘ stated in the guideline(s) is sloppy terminology. SCNR. I’m fine with 85–115% (80–120% at the LLOQ) of the true value or, if you prefer, ±15% (±20% at the LLOQ) inaccuracy. The term ‘non-accuracy’ is an invention of ICH. The proper terms are unambiguously defined by the ‘International Union of Pure and Applied Chemistry’ (founded 1919!) in its ‘Golden Book’:
— 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 |
avinash ★ India, 2023-07-03 10:21 (517 d 11:57 ago) @ Helmut Posting: # 23647 Views: 2,714 |
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Thank you Regards, Avinash |
Ohlbe ★★★ France, 2023-07-10 11:29 (510 d 10:49 ago) @ avinash Posting: # 23666 Views: 2,670 |
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Dear Avinash, ❝ Here does non-accuracy and precision validation runs means all other runs except accuracy and precision runs, which includes selectivity, specificity, matrix effect, carry-over, dilution integrity, stability and reinjection reproducibility? ❝ ❝ Please help me to understand what is non-accuracy and precision validation runs? My interpretation would be: all runs with quantitative assessments in matrix. For these runs, you would have QC samples, used for acceptance of the runs. Obviously this would not apply to e.g. stock or working solution stability. — Regards Ohlbe |
avinash ★ India, 2023-07-28 07:25 (492 d 14:53 ago) @ Ohlbe Posting: # 23687 Views: 2,486 |
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Thank you |