Safety assessment of biological raw materials in the system of medicines quality assurance-Reference-Cited by-同舟云学术

Safety assessment of biological raw materials in the system of medicines quality assurance

Published:2020-04-01 Issue:2 Volume: Page:63-72
ISSN:
Container-title:Novejshie zarubezhnye i otechestvennye lekarstvennye preparaty: farmakoterapija, farmakodinamika, farmakokinetika (Newest Foreign and Domestic Preparations: Pharmacotherapy, Pharmacodynamics, Pharmacokinetics)
language:ru
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Author:

Olefir Yu.¹,Sakanyan E.¹,Osipova I.¹,Dobrynin V.¹,Smirnova M.¹,Marakhova A.¹

Affiliation:

1. FSBI "Scientific Center for the Expertise of Medicinal Products" of the Ministry of Health of the Russian Federation

Abstract

The entry of a wide range of biotechnological products into the pharmaceutical market calls for rein-forcement of the quality, efficacy and safety standards at the state level. The following general monographs have been elaborated for the first time to be included into the State Pharmacopoeia of the Russian Federation, XIV edition: "Viral safety" and "Reduction of the risk of transmitting animal spongiform encephalopathy via medicinal products". These general monographs were elaborated taking into account the requirements of foreign pharmacopoeias and the WHO recommendations. The present paper summarises the key aspects of the monographs.

Publisher

PANORAMA Publishing House

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