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They say the ovarian test in particular has not been adequately validated and is being put on the market prematurely through a route that does not require approval by the Food and Drug Administration.
Still, some prostate cancer specialists say the test, which is called Prolaris and went on sale last year, has not been adequately validated, and sales have been very low.
Most models have not been adequately validated and reported performance has been unsatisfactory.
It is of note that none of these techniques have been adequately validated and that their use in laboratory settings is questionable.
The most widely used scale for measuring the clinical outcomes after this procedure, the American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal scale, has not been adequately validated and does not measure specific foot functions.
In the future toxicogenomics-based test methods may be shown to have been adequately validated and technically suitable for certain specific purposes, but regulatory acceptability and implementation will depend partly on whether the methods validated can be used for a given regulatory agency or program, that is, they are applicable to the products that fall within their regulatory purview.
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Any assay chosen for this purpose should be adequately validated and reproducible by other laboratories.
However, the current staging system has not been adequately validated for treatment planning and prognosis assessments.
Available instruments have not yet been adequately validated, each has methodological shortcomings and, to date, none have been universally incorporated into clinical practice.
We also review reports on assays that have been used to quantitate circulating levels of the HER-2/neu ECD, and we present evidence that not all HER-2/neu assays have been adequately validated, which has resulted in inaccurate data and uncertainty in the value of measuring the ECD of the HER-2/neu oncoprotein.
However, only two of these instruments have been adequately validated for use in the ICU: the Ramsay scale and the GCSC.
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