The draft FDA guideline on non-inferiority clinical trials: A critical review from European pharmaceutical industry statisticians

Pharmaceutical Statistics

Volumn 10, Issue 5, 2011, Pages 414-419

  Huitfeldt, Bernhard ^a   Hummel, Jürgen ^b  

^a BH Statistical Consulting   (Sweden)

^b Fleming House   (United Kingdom)

Author keywords

EFSPI; FDA guideline; fixed margin method; non inferiority; synthesis method

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; DRUG INDUSTRY; EUROPE; FOOD AND DRUG ADMINISTRATION; MEDICAL SOCIETY; PRACTICE GUIDELINE; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; EUROPE; GUIDELINES AS TOPIC; HUMANS; INTERNATIONALITY; PHARMACEUTICAL PREPARATIONS; RESEARCH; RESEARCH PERSONNEL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80053573170     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.508     Document Type: Article

References (12)

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