Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug–outcome association

Pharmacoepidemiology and Drug Safety

Volumn 25, Issue 9, 2016, Pages 973-981

  Gruber, Susan ^a,b   Chakravarty, Aloka ^a   Heckbert, Susan R ^c,d   Levenson, Mark ^a   Martin, David ^a   Nelson, Jennifer C ^e   Psaty, Bruce M ^c,d   Pinheiro, Simone ^a   Reich, Christian G ^f   Toh, Sengwee ^b   Walker, Alexander M ^g  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^d CENTER FOR HEALTH STUDIES   (United States)

^e UNIVERSITY OF WASHINGTON   (United States)

^f IQVIA   (United States)

^g WHISCON   (United States)

Author keywords

electronic health records; insurance claim data; medical product safety; monitoring; pharmacoepidemiology

Indexed keywords

AMPHOTERICIN B; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; BENZODIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BISPHOSPHONIC ACID DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; NEUROLEPTIC AGENT; TRICYCLIC ANTIDEPRESSANT AGENT; WARFARIN;

ACUTE KIDNEY FAILURE; ANGIONEUROTIC EDEMA; APLASTIC ANEMIA; ARTICLE; BLEEDING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EVALUATION STUDY; HEART INFARCTION; HIP FRACTURE; HUMAN; KIDNEY FAILURE; LIVER INJURY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RISK ASSESSMENT; UPPER GASTROINTESTINAL BLEEDING;

EID: 85027943139     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.4065     Document Type: Article

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