The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals

European Journal of Clinical Pharmacology

Volumn 69, Issue 2, 2013, Pages 217-226

  Ebbers, Hans C ^a   Mantel Teeuwisse, Aukje K ^a   Sayed Tabatabaei, Fakhredin A ^b   Moors, Ellen H M ^c   Schellekens, Huub ^a,c   Leufkens, Hubert G M ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Biopharmaceuticals; Periodic Safety Update Report; Pharmacovigilance; Safety

Indexed keywords

ANTINEOPLASTIC AGENT; HORMONE; IMMUNOMODULATING AGENT; INTERFERON; MONOCLONAL ANTIBODY; RECOMBINANT GROWTH FACTOR; RECOMBINANT HORMONE;

ARTICLE; CROSS-SECTIONAL STUDY; DRUG SAFETY; EUROPEAN UNION; FOLLOW UP; HEALTH CARE CONCEPTS; PERIODIC SAFETY UPDATE REPORT; PRIORITY JOURNAL; SCORING SYSTEM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOLOGICAL AGENTS; DRUG LABELING; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 84873730801     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1317-3     Document Type: Article

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