The European regulatory experience

Statistics in Medicine

Volumn 21, Issue 19, 2002, Pages 2931-2938

  Lewis, John A ^a,b  

^a Statistical and Regulatory Department   (United Kingdom)

^b Hatch Green Cottage   (United Kingdom)

Author keywords

Drug regulation; Guidelines; Medicinal products; Meta analysis; Non inferiority; Responders; Trial monitoring

Indexed keywords

DRUG;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG INDUSTRY; EUROPE; EXPERIENCE; HUMAN; META ANALYSIS; METHODOLOGY; MONITORING; SENSITIVITY ANALYSIS; STATISTICS; TREATMENT OUTCOME;

DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; EUROPE; HUMANS; LEGISLATION, DRUG; PHARMACEUTICAL PREPARATIONS; RANDOMIZED CONTROLLED TRIALS; THERAPEUTIC EQUIVALENCY;

EID: 0037108238     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1297     Document Type: Article

References (11)

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