Methods for observational post-licensure medical product safety surveillance

Statistical Methods in Medical Research

Volumn 24, Issue 2, 2015, Pages 177-193

  Nelson, Jennifer C ^a,b   Cook, Andrea J ^a,b   Yu, Onchee ^a   Zhao, Shanshan ^a,b   Jackson, Lisa A ^a,b   Psaty, Bruce M ^a,b  

^a GROUP HEALTH RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

Author keywords

data mining; observational study; post licensure safety; sequential testing

Indexed keywords

ARTICLE; DATA MINING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH HAZARD; MASKING; MAXIMUM LIKELIHOOD METHOD; OUTCOME ASSESSMENT; SEQUENTIAL ANALYSIS; STATISTICAL ANALYSIS; BIOSTATISTICS; COHORT ANALYSIS; DEVICE APPROVAL; DEVICE SAFETY; FACTUAL DATABASE; HUMAN; OBSERVATIONAL STUDY; PHASE 4 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA;

BIOSTATISTICS; CLINICAL TRIALS, PHASE IV AS TOPIC; COHORT STUDIES; DATA MINING; DATABASES, FACTUAL; DEVICE APPROVAL; EQUIPMENT SAFETY; HUMANS; OBSERVATIONAL STUDIES AS TOPIC; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES;

EID: 84928489552     PISSN: 09622802     EISSN: 14770334     Source Type: Journal    
DOI: 10.1177/0962280211413452     Document Type: Article

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