Examples of using Potency test in English and their translations into Romanian
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Programming
Antigenic units as determined in the in vitro potency test(ELISA).
Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Antibody titre obtained according to the in vivo potency test in chickens.
A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released.
The Community shall make arrangements for appropriate safety and potency testing of.
Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Antigenic units as determined in the in vitro potency test(antigenic mass assay).
Antigenic units 2 Flocculation equivalents; corresponds with≥ 30 IU/ ml guinea pig serum in the Ph. Eur. potency test.
Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in calves.
Flocculation equivalents; corresponds with≥ 30 IU/ml guinea pig serum in the Ph. Eur. potency test.
Inactivated bluetongue virus, serotype 8,strain BTV-8/BEL2006/02 RP*≥ 1*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
However, the submitted data demonstrated large variability in the test results of the reference batches in the serological potency test.
However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Inactivated whole avian influenza virus antigen of H7N1 subtype(strain, A/CK/Italy/473/99),inducing an HI titre of≥6.0 log2 as tested according to the potency test.
The distinction between what might be protective titres of antibodies andthe level of antibodies generated under the conditions of the batch potency test should be taken into account and the minimum potency at the time of batch release should be sufficient to provide the claimed duration of immunity.
Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units(as determined in the in vivo potency test in chickens).
The Marketing Authorisation(s)should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Inactivated whole avian influenza virus antigen of H5 subtype(strain H5N6, A/duck/Potsdam/2243/84),inducing an HI titre of≥6.0 log2 as tested according to the potency test.
Relative Potency unit determined by ELISA antigen quantification(in vitro potency test) compared to a reference vaccine.
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.
There are important outstanding issues regarding the differences of production and control between the manufacturing sites(including the nature of the eggs used) andthe lack of a validation study for the potency test on finished product(it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too).
And using this system,we can test the potency of cancer drugs.