A pathway to improved prospective observational post-authorization safety studies

Drug Safety

Volumn 35, Issue 9, 2012, Pages 711-724

  Kiri, Victor A ^a,b  

^a UNIVERSITY OF LIMERICK   (Ireland)

^b FVandJK Consulting Ltd   (United Kingdom)

Author keywords

Post marketing surveillance; Randomised controlled trials; Risk management

Indexed keywords

ACT; CLASSIFICATION; COMORBIDITY; CONFOUNDING VARIABLE; DATA ANALYSIS; DISEASE SEVERITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERNAL VALIDITY; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; POST AUTHORIZATION SAFETY STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; REVIEW; UNITED STATES; VALIDITY;

CLINICAL TRIALS AS TOPIC; DRUG TOXICITY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK MANAGEMENT;

EID: 84864974797     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11630570-000000000-00000     Document Type: Review

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