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Conversely, if different active sites of the biotherapeutic or different receptors of the target cells are involved in different therapeutic indications, or if the historical safety profile of the reference product differs qualitatively between the different therapeutic indications, additional data may need to be generated to justify the extrapolation of safety and efficacy data.

The use of an IgG 4 or IgG 2 isotype or use of an antibody containing mutations in the Fc region that minimize receptor binding and effector function would likely reduce the infusion reactions and cytokine release syndromes seen with a number of the licensed mAbs (mainly IgG 1).

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It accounts for up to 30% of all cases of nonischemic cardiomyopathy and may not necessarily correlate with the amount of alcohol consumed.

Borovnica pokazuje i niz drugih pozitivnih, svojstava, posebno kao dijetalno sredstvo kod akutnih i hronicnih oboljenja zeluca i zelucano-crijevnog trakta.

This was a Phase 3, parallel-group, randomized, multicenter, open-label, active-controlled study of women with epithelial ovarian carcinoma whose disease did not respond to or recurred after treatment with first-line chemotherapy with a platinum-based regimen.

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Sensitivity analysis for the prevalence of CKD was also performed using the Cockcroft-Gault (CG) equation to generate an estimate of creatinine clearance.

Red cell distribution width is associated with long-term prognosis in patients with stable coronary artery disease.

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Assessment of immunogenicity, therefore, already starts during the quality assessment of the biosimilar, where the physicochemical characteristics of the biosimilar and the reference product are extensively assayed, assessed and compared.

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However, testing for only one indication may not be sufficient to adequately explore the immunogenic potential of a biosimilar drug throughout several indications.

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The level of immunogenicity can be markedly different for products considered to be very similar.

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