Remarks on “Reply to the responses to the comments on “uncertainty profiles for the validation of analytical methods” by Saffaj and Ihssane”

Saffaj, Taoufiq; Ihssane, Bouchaîb

doi:10.1016/j.talanta.2012.12.002

Cited by 15 publications

(5 citation statements)

References 8 publications

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“…In a previous study we have demonstrated that our strategy provides a good estimate of measurement uncertainty compared to Feinberg's method that is based on the b-expectation tolerance interval. 45,46,51 We have found that Feinberg's method underestimates the routine uncertainty. Moreover, this statement was noted by Marini et al, 28 during a comparison between the estimates of the uncertainty in the validation study, the robustness study and the inter-laboratory study.…”

Section: Discussionmentioning

confidence: 97%

An overall uncertainty approach for the validation of analytical separation methods

Saffaj

Ihssane²,

Jhilal³

et al. 2013

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The aim of this paper is to recommend a new strategy for the analytical validation based on the uncertainty profile as a graphical decision-making tool, and to exemplify a novel method to estimate the measurement uncertainty. Indeed, the innovative formula that we offer to assess the uncertainty is based on the calculation of the β-content tolerance interval. Three chemometric methodologies are exposed to build the (β, γ) tolerance interval, namely: the Satterthwaite approximation, the GPQ method (generalized pivotal confidence) and the MLS procedure (modified large simple). Furthermore, we illustrate the applicability and flexibility of the uncertainty profile to assess the fitness of the purpose of chromatographic and electrophoretic analytical methods, which use different instrumental techniques such as liquid chromatography (LC-UV, LC-MS), gas chromatography (GC-FID, GC-MS) and capillary electrophoresis (CE, CE-MS). In addition, we demonstrate here that (β, γ) tolerance intervals will provide perfect estimates of the routine uncertainty. In particular, we show that there is no difference statistically between the uncertainties estimated by our methodology as of the validation stage with those obtained from the routine phase.

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Section: Discussionmentioning

confidence: 97%

An overall uncertainty approach for the validation of analytical separation methods

Saffaj

Ihssane²,

Jhilal³

et al. 2013

Analyst

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“…As reported by Saffaj et al, the β-content, c-confidence tolerance interval (β-CTI) could provide a better estimate of measurement risk than β-expectation tolerance interval and gave the best guarantee concerning the decision of declaring a method as valid and reliable [36][37][38]. Our previous work also revealed that the overall uncertainty estimated by the β-CTI from the total error (bias and standard deviation) was similar to the overall uncertainty assessed from validation data according to the trueness, precision, and robustness experiments [39].…”

Section: Introductionmentioning

confidence: 95%

Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits

Shi

Wang

et al. 2019

Journal of Spectroscopy

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The concept of real-time release testing (RTRT) has recently been adopted by the production of pharmaceuticals in order to provide high-level guarantee of product quality. Process analytical technology (PAT) is an attractive and efficient way for realizing RTRT. In this paper, near-infrared (NIR) determination of cryptotanshinone and tanshinoneIIA content in tanshinone extract powders was taken as the research object. The aim of NIR analysis is to reliably declare the extract product as compliant with its specification limits or not. First, the NIR quantification method was developed and the parameters of the multivariate calibration model were optimized. The reliable concentration ranges covering the specification limits of two APIs were successfully verified by the accuracy profile (AP) methodology. Then, with the designed validation data from AP, the unreliability graph as the decision tool was built. Innovatively, the β-content, γ-confidence tolerance intervals (β-CTIs) around the specification limits were estimated. During routine use, the boundary of β-CTIs could help decide whether the NIR prediction results are acceptable. The proposed method quantified the analysis risk near the specification limits and confirmed that the unreliable region was useful to release the product quality in a real-time way. Such release strategy could be extended for other PAT applications to improve the reliability of results.

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“…[9][10][11][12] The accuracy profile method was already used in the field of chromatographic determinations and is illustrated by numerous publications. [13][14][15][16] However, its use in the field of atomic spectrometry remains very rare. [17] Accuracy is the sum of trueness (systematic error) and precision (random errors).…”

Section: Introductionmentioning

confidence: 99%

Comparison of wavelength‐dispersive X‐ray fluorescence spectrometry and inductively coupled plasma optical emission spectrometry for the elementary determination in plants through the accuracy profile method

et al. 2018

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Accuracy profile is a graphical method, which allows to validate an analytical method. It defines a validity of a concentration range for a given accuracy. With this tool, quantitative determinations of macroelements and microelements (Al, Ca, Fe, K, Mg, Mn, Na, P, S, and Zn) in plant samples were evaluated by the use of a wavelength‐dispersive X‐ray fluorescence instrument. The method uses a simple preparation procedure with only drying, grinding, and pressing samples. The measured samples were reference materials with known mineral contents. The calibration procedure was established by employing plant materials issued from interlaboratory studies. Matrix effects were corrected by employing the method of the influence coefficients on the basis of the computerized routine program linked to the equipment. The accuracy profiles of the method show the measurements (trueness and precision) collected under intermediate precision conditions and aim to compute an acceptability interval where a known proportion of future results will be located. The various types of accuracy profile behavior were exemplified. In comparison with an inductively coupled plasma optical emission spectrometry method, the use of X‐ray fluorescence offers a good alternative, faster, and better precision. Inversely, inductively coupled plasma optical emission spectrometry offers an approach well suited for the trueness of measurements with very low matrix effects.

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Remarks on “Reply to the responses to the comments on “uncertainty profiles for the validation of analytical methods” by Saffaj and Ihssane”

Cited by 15 publications

References 8 publications

An overall uncertainty approach for the validation of analytical separation methods

An overall uncertainty approach for the validation of analytical separation methods

Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits

Comparison of wavelength‐dispersive X‐ray fluorescence spectrometry and inductively coupled plasma optical emission spectrometry for the elementary determination in plants through the accuracy profile method

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