A Review of Statistical Methods for Safety Surveillance

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 1, 2014, Pages 98-108

  Huang, Lan ^a   Guo, Ted ^a   Zalkikar, Jyoti N ^a   Tiwari, Ram C ^a  

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

Author keywords

disproportional signal; FDA Sentinel Initiative; passive surveillance; postmarket safety database

Indexed keywords

ATORVASTATIN; CLOPIDOGREL; METFORMIN; ROFECOXIB; ROSIGLITAZONE;

ARTICLE; BAYES THEOREM; CHI SQUARE DISTRIBUTION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HUMAN; LONGITUDINAL STUDY; MAXIMUM LIKELIHOOD METHOD; PRIORITY JOURNAL; RISK ASSESSMENT; SIGNAL DETECTION; STATISTICAL ANALYSIS; STATISTICAL MODEL;

EID: 84891528145     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013514236     Document Type: Article

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