Is pharmacovigilance of biologicals cost-effective?

Author:

Claus Barbara

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,Toxicology,Pharmacy

Reference11 articles.

1. Bouvy JC, Ebbers HC, Schellekens H, Koopmanschap MA. The cost-effectiveness of periodic safety update reports for biologicals in Europe. Clin Pharmacol Ther. 2013;93(5):433–42.

2. European Commission. The rules governing medicinal products in the European Union Guidelines on pharmacovigilance for medicinal products for human use. [Homepage on the Internet]. https://ec.europa.eu/health/human-use/pharmacovigilance_en (2012). Accessed 21 May 2018.

3. Giezen TJ, Mantel-Teeuwisse AK, Meyboom RH, Straus SM, Leufkens HG, Egberts TC. Mapping the safety profile of biologicals: a disproportionality analysis using the WHO adverse drug reaction database,VigiBase. Drug Saf. 2010;33(10):865–78. https://doi.org/10.2165/11538330-000000000-00000.

4. European Medicines Agency. Guidelines on good pharmacovigilance practices. EMA/529641/2016. 15 August 2016. [Homepage on the Internet]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211728.pdf (2016). Accessed 21 May 2018.

5. Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the food and drug administration between 2001 and 2010. JAMA. 2017;317(18):1854–63.

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