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- Although factor VIII activity determined by the chromogenic assay is generally lower than the Factor VIII activity determined by the one stage clotting assay, post infusion Factor VIII activities in patients with acquired haemophilia in clinical study OBI 1 301 tended to be higher when determined with the chromogenic assay than with the one stage clotting assay see section 4.4 .
- Bazedoxifene was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase TK locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary CHO cells, and in vivo mouse micronucleus assay.
- Bazedoxifene was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase TK locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary CHO cells, and in vivo mouse micronucleus assay.
- Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, assay robustness to quantities of Gazyvaro antibody in the circulation, sample handling, timing of sample collection, concomitant medicines and underlying disease.
- Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non activated chromosomal aberration assay in Chinese Hamster Ovary CHO cells and in the in vivo rat micronucleus assay.
- For patients who require aPTT monitoring within 120 hours of oritavancin dosing, a non phospholipid dependent coagulation test such as a Factor Xa chromogenic assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.
- For performance of the test, 200 ml 100 orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older as a pre administered test meal , as well as tap water for dissolving the 13C urea powder are necessary.
- A synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the Ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
- However, the mutagenic potential has been evaluated, and alitretinoin has tested negative in the Ames test, the in vivo mouse micronucleus assay, the chromosomal aberration test in human lymphocytes, and the CHO cell mutation test.
- Collagenase clostridium histolyticum was not mutagenic in Salmonella typhimurium AMES test and was not clastogenic in both an in vivo mouse micronucleus assay and an in vitro chromosomal aberration assay in human lymphocytes.
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