Determining the non-inferiority margin for patient reported outcomes

Pharmaceutical Statistics

Volumn 10, Issue 5, 2011, Pages 410-413

  Gerlinger, Christoph ^a   Schmelter, Thomas ^a  

^a BAYER PHARMA AG   (Germany)

Author keywords

choice of delta; ICH E10; non inferiority margin; patient reported outcomes

Indexed keywords

ACNE; ARTICLE; DISEASE ASSOCIATION; ENDOMETRIOSIS; HOT FLUSH; HUMAN; NON INFERIORITY MARGIN; PAIN ASSESSMENT; PATIENT SATISFACTION; PELVIS PAIN SYNDROME; SELF REPORT; STATISTICAL PARAMETERS; VISUAL ANALOG SCALE;

ACNE VULGARIS; ACNEIFORM ERUPTIONS; CLINICAL TRIALS AS TOPIC; DISCRIMINANT ANALYSIS; DISEASE PROGRESSION; DRUG AND NARCOTIC CONTROL; ENDOMETRIOSIS; FEMALE; HOT FLASHES; HUMANS; INTERNATIONALITY; MENOPAUSE; MODELS, STATISTICAL; PATIENT SATISFACTION; PELVIC PAIN; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; ROC CURVE; SELF REPORT; SENSITIVITY AND SPECIFICITY; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASOMOTOR SYSTEM;

EID: 80053565600     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.507     Document Type: Article

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