Examples of using Validated test in English and their translations into Slovak
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Therefore only validated tests with demonstrated high sensitivity should be used.
EGFR T790M mutationstatus should be determined by using a validated test method(see section 4.4).
If new, well validated, tests arise these may also be used in the total weight of evidence to be considered.
If a CE-marked IVD is not available,the HER2-status should be assessed by an alternate validated test.
RAS mutational status should be determined using a validated test method by an experienced laboratory(see section 4.2).
Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA(ctDNA) obtained from a plasma sample.
Before the use of 64Cu-labelled medicinal products,pregnancy should be excluded using an adequate/validated test.
Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS(exons 2, 3, and 4) and NRAS(exons 2, 3, and 4) mutations.
Detection of non-mutated KRAS expression shouldbe performed by an experienced laboratory using a validated test method.
ECVAM also issues recommendations on validated test methods summarising their performance and possible use for regulatory and non-regulatory purposes.
Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
Mutational status shouldbe determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS(exons 2, 3, and 4) mutations(see section 4.4 and 5.1).
Patients with NSCLC should be selected for treatmentbased on the tumour expression of PD-L1 confirmed by a validated test(see section 5.1).
Studies must be carried out using internationally validated test methods and shall be performed in accordance with European legislation in force or OECD Guidelines for methodological details and according to the principles of GLP.
BRCA mutation status should be determined by an experienced laboratory using a validated test method(see section 5.1).
When appropriate validated test methods become available, the Commission Regulation(EC) No 440/2008(2) and the Annexes to Regulation(EC) No 1907/2006 should be amended, if relevant, so as to replace, reduce or refine animal testing.
It is recommended that the detection of KRAS mutational statusbe performed by an experienced laboratory using a validated test method.
However, an immune response to eptotermin alfa should be considered andappropriate validated tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the medicinal product is ineffective.
Before taking vemurafenib, patients must have BRAFV600 mutation-positive tumour status confirmed by a validated test(see sections 4.4 and 5.1).
A major problem isthat for many endocrine disrupting effects, internationally agreed and validated test methods do not exist, although scientific tools and laboratory methods are available,” said Professor Susan Jobling from Brunel University in the United Kingdom.
Apart from lactose intolerance and celiac diseasethere is no accurate,reliable, and validated test to identify food intolerance.
Classification for heritable effects in human germ cells is made on the basis of well conducted,sufficiently validated tests, preferably as described in Regulation(EC) No 440/2008 adopted in accordance with Article 13(3) of Regulation(EC) No 1907/2006(‘Test Method Regulation') such as those listed in the following paragraphs.
However, regulators normally work harmonised OECD test guidelines orother internationally recognised and validated test methods.
In the case of studies initiated before the adoption ofthe modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;
Our technology is a combination of software algorithms(AI) and electronics, that works with off-the-shelfLi-ion batteries that have already been validated, tested, and produced by battery manufacturers.
Prior to initiating treatment with vemurafenib or dabrafenib,patients should be confirmed with the validated test of the V600 mutation of the BRAF gene.
Our technology is a combination of software algorithms(AI) and electronics, that works with off-the-shelfLi-ion batteries that have already been validated, tested, and produced by battery manufacturers.
Where relevant, be generated using test guidelines referred to or described in this Annex, in the case of studies initiated before the adoption of the modification of this Annex, theinformation shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;