The FDA’s Final Rule on Expedited Safety Reporting: Statistical Considerations

Statistics in Biopharmaceutical Research

Volumn 7, Issue 3, 2015, Pages 174-190

  Wittes, Janet ^a   Crowe, Brenda ^b   Chuang Stein, Christy ^c   Guettner, Achim ^d   Hall, David ^e   Jiang, Qi ^f   Odenheimer, Daniel ^g   Xia, H Amy ^f   Kramer, Judith ^h  

^a University of Iowa   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c PFIZER INC   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

^e Boehringer Ingleheim   (United States)

^f AMGEN INC   (United States)

^g Duke University ^*  (United States)

^h DUKE UNIVERSITY   (United States)

Author keywords

Expedited safety reporting; Final Rule on expedited safety reporting; Serious adverse events

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DATA PROCESSING; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EXPOSURE; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; MEASUREMENT ACCURACY; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; PROGRAM EFFICACY; STATISTICAL ANALYSIS;

EID: 84944044353     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1080/19466315.2015.1043395     Document Type: Article

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