Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

Author:

Michel ChristianeORCID,Scosyrev Emil,Petrin Michael,Schmouder Robert

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Reference37 articles.

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2. US Food and Drug Administration. Reports received and reports entered into FAERS by year (as of November 15, 2015). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm Accessed 10 Dec 2016.

3. Lindquist M. VigiBase, the WHO Global ICSR Database System: basic facts. Drug Inf J. 2008;42:409–19.

4. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP)—module IX—signal management. EMA/827661/2011. 2012. http://www.ema.europa.eu/ema/index . Accessed 23 Mar 2016 (online).

5. Bossard JB, Ponté C, Dupouy J, Lapeyre-Mestre M, Jouanjus E. Disproportionality analysis for the assessment of abuse and dependence potential of pregabalin in the French Pharmacovigilance Database. Clin Drug Investig. 2016;36:735–42.

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