The purpose of this paper is to unveil two novel statistical strategies to decide on the acceptability of an analytical and bioanalytical method transfer. These new approaches, namely the uncertainty assessment approach and the risk-based approach, are based on the measurement uncertainty as a decision-making tool. At first, we illustrate step by step all the calculations required to construct the maximum tolerated interval and the limits of uncertainty in the transfer phase from a Monte Carlo simulation. Then, we exemplify an original equation to assess the expected risk or probability that a receiving laboratory measurement will fall outside the maximum tolerated interval according to the estimated trueness, fidelity, and uncertainty parameters. We elucidate the applicability and flexibility of uncertainty approach as well as risk procedure to consider the fitness for purpose of analytical and bioanalytical methods in the transfer phase. We also demonstrate here that our approaches provide guarantees that each future measurement made by the receiving laboratory will be inside the specified acceptance limits. We show that there is no difference statistically between the decisions taken throughout the analytical transfer by our methodologies and those arising from the accuracy strategies.

New Approaches to Assess the Transfer of Analytical and Bioanalytical Methods Using Monte Carlo Simulation and Estimation of Uncertainty

In this article we develop procedures for one- and two-sided tolerance intervals for normal general linear models in which there exists a set of independent scaled chi-squared random variables. The proposed procedures are based on the concept of generalized pivotal quantities and are applicable to general mixed models provided that balanced data are available. However, this study focuses on situations involving unbalanced data. Specific attention is given to the unbalanced one-way random model. It is shown that the use of generalized pivotal quantities allows the construction of the tolerance intervals of interest fairly straightforward. Some practical examples are given to illustrate the proposed procedures. Furthermore, detailed statistical simulation studies are conducted to evaluate their performance, showing that the proposed procedures can be recommended for practical use.

One- and two-sided tolerance intervals for general balanced mixed models and unbalanced one-way random models

Full validation using β-content, γ-confidence tolerance interval: Application for LC-MS/MS determination of Doxycycline in human plasma

ABSTRACT The quality of quantitative results in bioanalysis requires not only a validated analytical method but also a rigorous estimation of measurement uncertainty. This study examines the challenges associated with the implementation of two distinct approaches in equine anti‐doping control for the assessment of uncertainty associated with an ultra‐high‐performance liquid chromatography‐high resolution mass spectrometry quantitative method for caffeine and lidocaine in horse urine. The bottom‐up approach, based on the ISO Guide to the Expression of Uncertainty in Measurement (ISO GUM), was compared to the top‐down approach using β‐content, γ‐confidence tolerance intervals (β,γ‐CCTI) via F‐test. The key limitation of the ISO GUM method was accurately quantifying the various uncertainty components; it gives standardized uncertainty estimates but requires detailed assumptions and modeling about error sources. The direct application of the GUM method imposes the beforehand correction of the matrix effect to provide reliable results. Parallelly, the chemometric approach β,γ‐CCTI offers more flexible and realistic estimations. Four combinations of β and γ were investigated to assess their influence on uncertainty interval width: β = 66.7% and 80%; γ = 90% and 95%; and the method was evaluated under repeatability and intermediate precision conditions through the use of advanced computation that adjusts for matrix effects and proves more straightforward for capturing variability inherent in experimental data. The top‐down approach is a reliable alternative for routine use and, particularly, for ensuring compliance with regulatory requirements, with the fact that a known proportion β of future results will be within predefined acceptance limits. 

Bioanalytical Uncertainty Assessment of Ultra‐High‐Performance Liquid Chromatography‐High Resolution Mass Spectrometry Method for Caffeine and Lidocaine in Equine Antidoping: A Dual Perspective on Bottom‐up and Top‐Down Approaches

Objective: A new and powerful statistical approach known as the uncertainty profile concept has been suggested for both testing the validity and making easy and straightforward interpretation of results obtained during the validation of an analytical method. The main goal of this paper is to confirm the applicability of this new strategy for the validation of a commercial kit, microbiological method, for the enumeration of the Enterobacteriaceae in foods and the estimate of the measurement uncertainty by using the newly provided formula and without referring to any additional experiments. Methods: An innovative formula to assess the uncertainty by using validation data and without recourse to other additional experiments was proposed. The uncertainty was evaluated through the two-sided β-content, γ-confidence tolerance interval, which is computed with three manners: the Mee’s approach, the Generalized Pivotal Confidence, and the Modified Large Simple procedure Results: After the use of the three chemometric method of calculation of tolerance intervals, the obtained results with uncertainty profile show without doubt that the enumeration method is valid over the range of target values given that the upper and the lower 66.7 %-content, 90 %-confidence tolerance limits have fallen within the two acceptance limits of±0.25 Log unit. If the β is stretched to 80 %-content, 90 %-confidence, the three computed tolerance intervals lead to different decisions. Conclusion: we have demonstrated the ability of the uncertainty profile to be used for testing the validity of enumeration method which represents the first application of an uncertainty profile to food microbiological methods, and provides good estimations of the uncertainty measurements for each concentration level. Keywords : Validation, Uncertainty profile, β-content-γ-confidence tolerance interval, Uncertainty measurement, Microbiological method

An innovative strategy based on uncertainty profile for the validation of microbiological methods for counting enterobacteriaceae in foods

Objective: A new and powerful statistical approach known as the uncertainty profile concept has been suggested for both testing the validity and making easy and straightforward interpretation of results obtained during the validation of an analytical method. The main goal of this paper is to confirm the applicability of this new strategy for the validation of a commercial kit, microbiological method, for the enumeration of the Enterobacteriaceae in foods and the estimate of the measurement uncertainty by using the newly provided formula and without referring to any additional experiments. Methods: An innovative formula to assess the uncertainty by using validation data and without recourse to other additional experiments was proposed. The uncertainty was evaluated through the two-sided β-content, γ-confidence tolerance interval, which is computed with three manners: the Mee’s approach, the Generalized Pivotal Confidence, and the Modified Large Simple procedure Results: After the use of the three chemometric method of calculation of tolerance intervals, the obtained results with uncertainty profile show without doubt that the enumeration method is valid over the range of target values given that the upper and the lower 66.7 %-content, 90 %confidence tolerance limits have fallen within the two acceptance limits of±0.25 Log unit. If the β is stretched to 80 %-content, 90 %-confidence, the three computed tolerance intervals lead to different decisions. Conclusion: we have demonstrated the ability of the uncertainty profile to be used for testing the validity of enumeration method which represents the first application of an uncertainty profile to food microbiological methods, and provides good estimations of the uncertainty measurements for each concentration level.

AN INNOVATIVE STRATEGY BASED ON UNCERTAINTY PROFILE FOR THE VALIDATION OF MICROBIOLOGICAL METHODS FOR COUNTING ENTEROBACTERIACEAE IN FOODS Original Article

Popular Tasks used by Researchers

How can I help with your research?

Get more enhanced response by uploading the PDFs you want me to reference.

No relevant PDFs in your library

SciSpace is the AI research assistant for academics. Run systematic literature reviews on 280M+ papers, and write papers with cited sources. Trusted by 1M+ students, PhDs & researchers.

SciSpace | AI for Research

We encountered an error while loading the panel. Please try refreshing the page.

Something went wrong

Analyze PDFs

Code & Manuscripts

Funding & Grants

Literature & Patents

Medical & Clinical Data

Systematic Review

Visualize & Present

Web & Data

Build a Google Scholar-like website for your research.

Build a website

Create charts and images for your research

Create a Chart

Write a paper for submission to a journal

Draft a manuscript

Patent Search

Design eye-catching scientific posters in minutes.

Scientific Poster Generation

Systematic Literature Review

Anyone with the link can view this chat. You can switch it back to private anytime.

One task is running at the moment. Your messages will be shown right after.

Drag and drop or click here to browse

Loved by <highlight>1 million+</highlight> researchers

Extract a list of specific topics and their sources from unstructured text

Topics

Compare and analyze relevant papers that matches with your search

Papers

Get insights from PDFs and bookmarked papers from your library

My library

Recent searches

Try searching for:

Catch AI-generated content in scholarly and non-scholarly content

{ai} Detector

Ai Writer

Get PDF Summaries, highlighted text explanations 

Chat with PDF

Effortlessly create in-text citations and bibliographies in APA and 2,500 other formats

Citation generator

Get explanations, summaries, and answers on academic papers

Ease up your research workflow with {scispace}'s cohort of exciting AI tools

Elevate your academic writing skills and convey your ideas the way you want

Paraphraser

Explore our range of reading and writing tools

Your file is being prepared and should be ready in a few minutes. If it's a large file, it might take a bit longer. You can close this window, and we'll email you the file when it's done.

You have reached a maximum limit of <strong>{limit}</strong> columns in the table. Remove at least <strong>1</strong> column to add or create another one.

Saad S. Alaoui

Author Tools

Chat about Author

Papers

An innovative strategy based on uncertainty profile for the validation of microbiological methods for counting enterobacteriaceae in foods

AN INNOVATIVE STRATEGY BASED ON UNCERTAINTY PROFILE FOR THE VALIDATION OF MICROBIOLOGICAL METHODS FOR COUNTING ENTEROBACTERIACEAE IN FOODS Original Article