Examples of using Validated test in English and their translations into Romanian
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EGFR T790M mutation status 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.
Before taking trametinib,patients must have confirmation of BRAF V600 mutation using a validated test.
RAS mutational status should be determined using a validated test method by an experienced laboratory(see section 4.2).
If a CE-marked IVD is not available,the HER2-status should be assessed by an alternate 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 taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
ECVAM also issues recommendations on validated test methods summarising their performance and possible use for regulatory and non-regulatory purposes.
Detection of non-mutated KRAS expression should be performed by an experienced laboratory using a validated test method.
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.
Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
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.
Before taking Cotellic in combination with vemurafenib,patients must have BRAF V600 mutation- positive tumour status confirmed by a validated test.
However, an immune response to eptotermin alfa should be considered and appropriate 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.
It is recommended that the detection of KRAS mutational status be performed by an experienced laboratory using a validated test method.
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.
Before taking trametinib or the combination with dabrafenib,patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Such a review should be primarily driven by scientific advice and technical issues related to the control and enforcement of the new measures;it would also be linked to the availability of validated tests to distinguish between PAPs originating from different species and the channelling of the PAPs manufacture according to species.
Before taking dabrafenib or combination with trametinib, patients must have BRAF V600 mutation- positive tumour status confirmed by a validated test.
Point 1.2 of the introduction to Annexes II and III is replaced by the following:'1.2 where relevant, be generated using test guidelines, according to the latest adopted version, referred to or described in this Annex; in the case of studies initiated before the entry into force of the 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;'.
Patients treated with Perjeta must have HER2-positive tumour status,defined as a score of 3+ by immunohistochemistry(IHC) and/or a ratio of≥ 2.0 by in situ hybridisation(ISH) assessed by a validated test.
It should only be started after the presence of wild-type RAS(KRAS and NRAS genes)has been confirmed by an experienced laboratory using a validated test method.
Patients are eligible for Lynparza treatment if they have a confirmed deleterious or suspected deleterious BRCA mutation(i.e. a mutation that disrupts normal gene function) in either the germline orthe tumour(detected using an appropriately validated test).
We validate, test and implement the agreed solution using specific risk management methodologies.
This test validated many backend changes to the game flow for more reliable game starts.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
(5) The test requirements for dogs andcats imported from Malaysia must be modified so as to allow the use of a validated diagnostic test for the detection of antibody against Nipah disease virus.