The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals
The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals
About this item
Full title
Author / Creator
Publisher
Berlin/Heidelberg: Springer-Verlag
Journal title
Language
English
Formats
Publication information
Publisher
Berlin/Heidelberg: Springer-Verlag
Subjects
More information
Scope and Contents
Contents
Purpose
To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals.
Methods
A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a...
Alternative Titles
Full title
The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals
Authors, Artists and Contributors
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3548093
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3548093
Other Identifiers
ISSN
0031-6970
E-ISSN
1432-1041
DOI
10.1007/s00228-012-1317-3
