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In the EU, these tests must first undergo validation studies of sensitivity and specificity against panels of frozen sera or plasma collected during primary infection and covering the principal HIV variants, previously tested with reference EIA and Western blot methods [9], [10].
Unfortunately, many models are developed yet only a limited portion of these undergo validation in various clinical settings.
In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation.
Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation.
This is because not only will the technology itself need to be standardized and validated, but the methods that are based upon the technology and their predictive aspects will also need to undergo validation if they are to be employed in regulatory decision-making processes.
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Several of these assays have been validated or are currently undergoing validation in several laboratories and are > 80% concordant with in vivo results.
This signifies that the criteria set has been quantitatively validated using patient data, and it has undergone validation based on an independent data set.
We used two well established in vitro mammalian cell-based assays [ 16, 17] validated by ICCVAM/NICEATM/OECD (BG1Luc assay) or that has been undergoing validation (MCF-7 assay: [ 18]).
Uniquely for cancer prognostic biomarkers, uPA and PAI-1 have undergone validation in two separate LOE-1 studies; that is, both have been validated in a prospective randomized controlled trial (NCT1317108) and in a pooled analysis of individualized patient characteristics.
Although a number of simulators have been introduced for prostate surgery, none have undergone validation for holmium laser enucleation of the prostate training.
Clinical dehydration scale (CDS) has been developed and undergone validation for measuring dehydration in children.
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