Bioequivalence and Bioavailability Forum • non-accuracy and precision validation runs in ICH M10 guideline

avinash
★

India,
2023-06-30 11:28
(472 d 21:45 ago)

Posting: # 23636
Views: 2,954

non-accuracy and precision validation runs in ICH M10 guideline [Regulatives / Guidelines]

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
(472 d 19:40 ago)

@ avinash
Posting: # 23637
Views: 2,487

Inaccuracy, precision acc. to IUPAC

Post reply

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’:

Accuracy (p. 18)
Closeness of the agreement between the result of a measurement and a true value of the measurand.
Notes:
1. Accuracy is a qualitative concept.
2. The term precision should not be used for accuracy.

Inaccuracy (p. 722)
A quantitative term to describe the (lack of) accuracy of a chemical measurement process; comprises the imprecision and the bias. Inaccuracy must be viewed as a two-component quantity (vector); imprecision and bias should never be combined to give a scalar measure for chemical measurement process inaccuracy. (One or the other component may, however, be negligible under certain circumstances.) Inaccuracy should not be confused with uncertainty. Inaccuracy (imprecision, bias) is characteristic of the measurement process, whereas error and uncertainty are characteristics of a result. (The latter characteristic, of course, derives from the imprecision and bounds for bias of the chemical measurement process.)
Note:
The resultant bias and imprecision for the overall measurement process generally arise from several individual components, some of which act multiplicatively (e.g. sensitivity), and some of which act additively (e.g. the blank).
Precision (p. 1173)
The closeness of agreement between independent test results obtained by applying the experimental procedure under stipulated conditions. The smaller the random part of the experimental errors which affect the results, the more precise the procedure. A measure of precision (or imprecision) is the standard deviation.
Comment:
Precision is sometimes misused for accuracy. This problem will be avoided if one recognizes that precision relates only to dispersion, not to deviation from the (conventional) true value. Imprecision has been defined as ‘the standard error of the reported value.’
Imprecision (p. 720)
Variation of the result in a set of replicate measurements. This can be expressed, e.g. as the standard deviation or coefficient of variation (relative standard deviation). This term may have a more general meaning, e.g. if the replicates constitute a batch or involve different instruments, laboratories and analyst.

The fact that I have a heart does not qualify me to write a guideline for cardiology.

—
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 (469 d 22:53 ago) @ Helmut Posting: # 23647 Views: 2,488	Inaccuracy, precision acc. to IUPAC Post reply
	Thank you Regards, Avinash

Ohlbe
★★★

France,
2023-07-10 11:29
(462 d 21:45 ago)

@ avinash
Posting: # 23666
Views: 2,452

non-accuracy and precision validation runs in ICH M10 guideline

Post reply

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 (445 d 01:49 ago) @ Ohlbe Posting: # 23687 Views: 2,264	non-accuracy and precision validation runs in ICH M10 guideline Post reply
	Thank you