Considerations for the Bioanalytical Part of Equivalence Studies of Biosimilar Nadroparin Calcium

Considerations for the Bioanalytical Part of Equivalence Studies of Biosimilar Nadroparin Calcium

According to current regulatory views, a comparative study of the pharmacodynamics (PD) of low molecular weight heparin (LMWH) products and confirmation of their equivalence require comparing three PD markers: the anti-Xa activity, the anti-IIa activity, and the tissue factor pathway inhibitor (TFPI...

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Bibliographic Details
Main Authors: V. M. Kosman, M. V. Karlina, N. M. Faustova, E. A. Ezhova, I. G. Kotelnikova, V. G. Makarov, M. N. Makarova
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2023-03-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
comparative pharmacodynamics
biosimilar medicinal product
nadroparin calcium
single subcutaneous administration
low molecular weight heparins
anti-xa activity
anti-iia activity
tissue factor pathway inhibitor
surrogate pharmacokinetic markers
Online Access:https://www.vedomostincesmp.ru/jour/article/view/406
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