Regulatory Scientific Advice on Non-Inferiority Drug Trials

PLoS ONE

Volumn 8, Issue 9, 2013, Pages

  Wangge, Grace ^a,b   Putzeist, Michelle ^a,b   Knol, Mirjam J ^c   Klungel, Olaf H ^a   Gispen De Wied, Christine C ^b   de Boer, Antonius ^a   Hoes, Arno W ^d   Leufkens, Hubert G ^a,b   Mantel Teeuwisse, Aukje K ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; GASTROINTESTINAL AGENT; HORMONE; IMMUNOMODULATING AGENT; ORPHAN DRUG; RESPIRATORY TRACT AGENT;

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG EFFICACY; INTENTION TO TREAT ANALYSIS; METHODOLOGY; NON INFERIORITY DESIGN; PRACTICE GUIDELINE; SAMPLE SIZE; STUDY DESIGN;

CONTROLLED CLINICAL TRIALS AS TOPIC; DRUG INDUSTRY; DRUG THERAPY; EUROPE; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84883521808     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0074818     Document Type: Article

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