Active and passive surveillance of enoxaparin generics: A case study relevant to biosimilars

Expert Opinion on Drug Safety

Volumn 14, Issue 3, 2015, Pages 349-360

  Grampp, Gustavo ^a   Bonafede, Machaon ^b   Felix, Thomas ^a   Li, Edward ^c   Malecki, Michael ^a   Sprafka, J Michael ^a  

^a AMGEN INC   (United States)

^b IBM WATSON HEALTH   (United States)

^c UNIVERSITY OF NEW ENGLAND   (United States)

Author keywords

Biosimilar; Enoxaparin; Pharmacovigilance; Safety surveillance

Indexed keywords

BIOSIMILAR AGENT; ENOXAPARIN; GENERIC DRUG; ANTICOAGULANT AGENT;

ADULT; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BLEEDING; DATA BASE; DIARRHEA; DRUG SAFETY; EDEMA; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MEDICARE; NAUSEA; PHARMACY; SIDE EFFECT; CHEMICALLY INDUCED; DRUG SURVEILLANCE PROGRAM; POSTMARKETING SURVEILLANCE; PROCEDURES; RETROSPECTIVE STUDY; THROMBOCYTOPENIA; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTICOAGULANTS; BIOSIMILAR PHARMACEUTICALS; DRUGS, GENERIC; ENOXAPARIN; FEMALE; HUMANS; INCIDENCE; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; THROMBOCYTOPENIA; UNITED STATES;

EID: 84923356961     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2015.1001364     Document Type: Article

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