Huitfeldt, Bernhard <br/><br/>
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 
<br/><br/> Publication Type: Journal Article; Review 
<br/><br/><label>ISSN: </label>1539-1612 
<br/><br/><label>Standard No.: </label>10.1002/pst.508  doi 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Clinical Trials as Topic--legislation & jurisprudence<br/>Drug Industry--statistics & numerical data<br/>Drug and Narcotic Control--statistics & numerical data<br/>Drug-Related Side Effects and Adverse Reactions<br/>Europe<br/>Guidelines as Topic<br/>Humans<br/>Internationality<br/>Pharmaceutical Preparations--metabolism<br/>Research--legislation & jurisprudence<br/>Research Personnel<br/>United States<br/>United States Food and Drug Administration