The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians.
Huitfeldt, Bernhard
The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians. [electronic resource] - Pharmaceutical statistics - 414-9 p. digital
Publication Type: Journal Article; Review
1539-1612
10.1002/pst.508 doi
Clinical Trials as Topic--legislation & jurisprudence
Drug Industry--statistics & numerical data
Drug and Narcotic Control--statistics & numerical data
Drug-Related Side Effects and Adverse Reactions
Europe
Guidelines as Topic
Humans
Internationality
Pharmaceutical Preparations--metabolism
Research--legislation & jurisprudence
Research Personnel
United States
United States Food and Drug Administration
The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians. [electronic resource] - Pharmaceutical statistics - 414-9 p. digital
Publication Type: Journal Article; Review
1539-1612
10.1002/pst.508 doi
Clinical Trials as Topic--legislation & jurisprudence
Drug Industry--statistics & numerical data
Drug and Narcotic Control--statistics & numerical data
Drug-Related Side Effects and Adverse Reactions
Europe
Guidelines as Topic
Humans
Internationality
Pharmaceutical Preparations--metabolism
Research--legislation & jurisprudence
Research Personnel
United States
United States Food and Drug Administration