The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians-Reference-Cited by-同舟云学术

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

Published:2011-09 Issue:5 Volume:10 Page:414-419
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Huitfeldt Bernhard¹,Hummel Jürgen²,

Affiliation:

1. BH Statistical Consulting; Stenåsvägen 2; 155 33; Nykvarn; Sweden

2. PPD Inc, Fleming House, Phoenix Crescent; Strathclyde Business Park; Bellshill; North Lanarkshire; ML4 3NJ; UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference12 articles.

1. Temple RJ Active Control Non-Inferiority Studies: Theory, Assay Sensitivity, Choice of Margin Presentation given on 19 February 2002 http://www.fda.gov/ohrms/dockets/ac/02/slides/3837s1\_02\_Temple.ppt

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