Chemistry International Blank Image
Chemistry International Text Image Link to Chemistry International Blank Image Chemistry International Blank Image Chemistry International Blank Image
Chemistry International Blank Image
Chemistry International Blank Image
Chemistry International Text Image Link to Current Issue
Chemistry International Text Image Link to Past Issues
Chemistry International Text Image Link to Officer's Columns
Chemistry International Text Image Link to Features
Chemistry International Blank Image
Chemistry International Text Image Link to Up for Discussion
Chemistry International Text Image Link to IUPAC Wire
Chemistry International Text Image Link to Project Place
Chemistry International Text Image Link to imPACt
Chemistry International Text Image Link to Bookworm
Chemistry International Text Image Link to Internet Connections
Chemistry International Text Image Link to Conference Call
Chemistry International Text Image Link to Where 2B and Y
Chemistry International Text Image Link to Symposia
Chemistry International Text Image Link to CI Indexes
Chemistry International Text Image Link to CI Editor
Chemistry International Text Image Link to Search Function
Chemistry International Text Image Link to Information

 

Chemistry International Text Image Link to Previous Issue Chemistry International Text Image Link to Previous Page Chemistry International Text Image Link to This TOC Chemistry International Text Image Link to Next Page Chemistry International Text Image Link to Next Issue

Vol. 31 No. 6
November-December 2009

The Project Place | Information about new, current, and complete IUPAC projects and related initiatives
See also www.iupac.org/projects

Experimental Requirements for Single-Laboratory Validation

The objective of this recently initiated project is to provide expert guidance on the scope and scale of experiments required for single-laboratory method validation, enabling regulatory agencies to harmonize validation requirements.

This new project will develop guidance on experimental designs suitable for determining method performance characteristics during single laboratory validation experiments. Where possible, the resulting report will include guidance on numerical values for such performance characteristics.

The output is intended to support implementation of the existing IUPAC Harmonized Protocol on Single-Laboratory Validation (PAC 2002, Vol. 74, No. 5, pp. 835–855), which specifies the performance characteristics to be assessed, but currently includes no quantitative guidance on the scale of experimentation required.

It is currently envisaged that the guidance will be informed by statistical power considerations; that is, experimental requirements will be set so as to achieve a particular probability of correctly identifying significant adverse effects (such as a specified upper limit for bias). The guidance will indicate the power appropriate for different situations. For example, verification of performance of an established method, validation of a new method, or validation of a new method intended for critical uses would attract increasingly stringent requirements. It is envisaged that the report will include example simple-experiment designs and associated tables of replicate numbers for each such situation so that regulators can easily specify the level of stringency required and analysts can easily identify the scale of experimentation necessary to meet the requirement.

The requirements will be chosen so that they broadly reflect and harmonize current best practice. The advantage of specifying requirements in terms of test power as well as listing specific experiments and experiment sizes is that it then becomes possible to permit any experiment design that is designed to achieve the necessary confidence. This provides for flexibility in specifying single-laboratory validation requirements, and allows analysts to design improved experiments which have greater efficiency while being able to demonstrate that the stringency is sufficient.

For more information and comments, contact Task Group Chair Steven L.R. Ellison <s.ellison@lgc.co.uk>.


www.iupac.org/web/ins/2009-006-1-500


Page last modified 6 November 2009.
Copyright © 2003-2009 International Union of Pure and Applied Chemistry.
Questions regarding the website, please contact edit.ci@iupac.org
Link to CI Home Page Link to IUPAC E-News Link to IUPAC Home Page