Demonstrating therapeutic equivalence of a new and established pharmaceutical or intervention: a guide for the non-statistician
Author:
Affiliation:
1. Department of Anesthesia; University of California-San Francisco; San Francisco California
2. Statistics and Actuarial Science; University of Waterloo; Waterloo Ontario Canada
Publisher
Wiley
Subject
Hematology,Immunology,Immunology and Allergy
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/trf.14061/fullpdf
Reference10 articles.
1. Understanding non-inferiority trials and tests for the non-statistician: when to use them and how to interpret them;Weiskopf;Transfusion
2. Trials to assess equivalence: the importance of rigorous methods;Jones;BMJ,1996
3. Food and Drug 2015
4. Equivalent efficacy of hydroxyethyl starch 130/0.4 and human serum albumin: if nothing is the same, is everything different? The importance of context in clinical trials and statistics;Weiskopf;Anesthesiology,2013
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