fit‐for‐purpose approachimmunoassay methodologiesRecent advances in genomic, proteomic, and metabolomic research have resulted in an explosion of novel biomarkers that are increasingly being utilized across all stages of the drug development process to help guide decisions around the efficacy and safety ...
Robust distances are mainly used for the purpose of detecting multivariate outliers. The precise definition of cut-off values for formal outlier testing as... A Cerioli,A Farcomeni,M Riani - 《Computational Statistics & Data Analysis》 被引量: 24发表: 2013年 Measurement of the Effects of Pur...
They can also be classified based on the underlying technology, each with distinct features and performance characteristics, which require bench and human experimentation testing phases. In contrast to laboratory biomarkers, digitally measured biomarkers require prospective data collection for purposes of ...
Purpose - The purpose of this paper is to use competence theory to explore the fit between actual competencies of quality management (QM) practitioner and the perception of QM competence needs in organisations. Design/methodology/approach - This paper is based on a cross-case quantitative study de...
Selection: a question of 'fit for purpose' This article examines three elements of the selection process utilized by the Division of Midwifery and Women's Health, within one institution, to ensure that students are 'fit for purpose', i.e. can effectively meet the theoretical and ... M ...
However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve ...
Apply 'user testing' methodology to test the readability of a European Public Assessment Report (EPAR) summary—which describes how the decision was made by the European Medicines Agency to approve a medicine. User testing uses mixed methods (questionnaire and semistructured interview), applied iterat...
case. The two most important reasons for this, said the judges, are that,“the test’s reliability depends on the number of cycles used’’and that“the test’s reliability depends on the viral load present.’’In other words, there are simply too many unknowns surrounding PCR testing. ...
Evaluating goodness-of-fit indexes for testing MI Many statistical techniques were originally invented for the purpose of making comparisons between and among groups of entities. Not surprisingly, difficul... GW Cheung,RB Rensvold - 《Structural Equation Modeling A Multidisciplinary Journal》 被引量: ...
clinical end point. Ultimately, fit-for-purpose requires an assessment of the technical ability of the assay to deliver against the predefined purpose. Abbreviations: IHC=immunohistochemistry; LBA=ligand binding assay; MS=mass spectrometry; PD=pharmacodynamic; POM=proof of mechanism; POC=proof of ...