Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases-Reference-Cited by-同舟云学术

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

Published:2013-06-15 Issue:8 Volume:36 Page:617-625
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Vermeer Niels S.,Straus Sabine M. J. M.,Mantel-Teeuwisse Aukje K.,Domergue Francois,Egberts Toine C. G.,Leufkens Hubert G. M.,De Bruin Marie L.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/content/pdf/10.1007/s40264-013-0073-3.pdf

Reference36 articles.

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2. Declerck PJ. Biotherapeutics in the era of biosimilars: what really matters is patient safety. Drug Saf. 2007;30(12):1087–92.

3. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346(7):469–75.

4. Ebbers HC, Mantel-Teeuwisse AK, Moors EH, Schellekens H, Leufkens HG. Today’s challenges in pharmacovigilance: what can we learn from epoetins? Drug Saf. 2011;34(4):273–87.

5. Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22(11):1383–91.

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