SAFETY OF BIOPHARMACEUTICALS: FACING NEW REALITIES



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Abstract

Background: A greatnumber of biopharmaceuticals has been implemented for clinical practice in recent years. Clinical relevance of these drugs is increasing. Results: Authors made a systematic review of adverse events of biopharmaceuticals from 1990 to 2014. We searched information about safety of biopharmaceuticals in international data bases. Inclusion criteria were safety profile of immunodepressant and antitumor drugs. Conclusion: We determine the difference between biopharmaceuticals and small molecules in case of adverse events. Adverse event classification was assessed. We made a guideline for Russian Pharmacovigilance System.

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About the authors

A S Kolbin

First Pavlov State Medical University of St. Petersburg; St. Petersburg State University

A A Toporov

First Pavlov State Medical University of St. Petersburg

Email: zenoantaneho@gmail.com

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