Collaborative study for the establishment of the Ph. Eur. Hepatitis E virus RNA for NAT testing biological reference preparation batch 1

Autor: S A, Baylis, E, Terao, J, Blümel, K-M O, Hanschmann
Rok vydání: 2017
Předmět:
Zdroj: Pharmeuropa bioscientific notes. 2017
ISSN: 2075-2504
Popis: A new European Pharmacopoeia (Ph. Eur.) biological reference preparation (BRP) had to be established further to the decision to include nucleic acid testing (NAT) for the detection of hepatitis E virus (HEV) RNA in the monograph Human plasma (pooled and treated for virus inactivation) (1646). To this purpose, an international collaborative study was launched in the framework of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of MedicinesHealthCare (EDQM) and the Commission of the European Union (EU). The study was run in conjunction with the establishment of the 1
Databáze: OpenAIRE