Principles for clinical trials of coagulation factor IX products
https://doi.org/10.34215/1609-1175-2020-3-11-18
Abstract
Review of materials related to scientific principles underlying clinical trials of coagulation factor IX medications obtained using recombinant DNA technique or from donors’ blood plasma. Inherited deficiency of functional active coagulation factor IX or a low level of its synthesis lead to the development of hemophilia B. Patients with hemophilia require a continuous replacement therapy with factor IX medications. Achievements in the area of genetically engineering technologies as well as improvement of production process of biological products allow developing modern highly efficient medications which are successfully used to treat patients with hemophilia. Registration of newly developed medications and medications produced according to the modified technology requires clinical trials. Principles of these trials are regulated by the clauses of regularly updated regulatory documents. Compliance with national and international guidelines determining the conditions for clini‑ cal trials of medications allows us to guarantee their safety and promotes the development of medications efficient to treat patients with hemophilia.
About the Authors
Zh. I. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products, Moscow
Russian Federation
Russian Federation
MD, PhD, professor, chief expert of the Center for Examination and Control,
41 Sivtsev Vrazhek St., Moscow, 121002
A. A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
MD, PhD, chief expert of the Office of Expertise Allergens, Cytokines and Other Immunomodulators,
41 Sivtsev Vrazhek St., Moscow, 121002
V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
MD, PhD, professor, director of the Centre of Expertise of the Medical Immunobiological Preparations Quality,
41 Sivtsev Vrazhek St., Moscow, 121002
V. A. Merkulov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
MD, PhD, professor, deputy director general for the expertise of drugs,
41 Sivtsev Vrazhek St., Moscow, 121002
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Review
For citations:
Avdeeva Zh.I., Soldatov A.A., Bondarev V.P., Merkulov V.A. Principles for clinical trials of coagulation factor IX products. Pacific Medical Journal. 2020;(3):11-18. (In Russ.) https://doi.org/10.34215/1609-1175-2020-3-11-18
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