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透过玻璃看：理解非劣效性。

Through the looking glass: understanding non-inferiority.

机构信息

Statistics Collaborative, Inc, Washington DC 20036, USA.

出版信息

Trials. 2011 May 3;12:106. doi: 10.1186/1745-6215-12-106.

DOI:10.1186/1745-6215-12-106
PMID:21539749
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3113981/
Abstract

Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

摘要

非劣效性试验旨在检验一种新产品是否不比已上市产品差得不可接受。本文介绍了与非劣效性相关的概念，并讨论了欧洲药品管理局和美国食品药品监督管理局的监管观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/9441857b4f57/1745-6215-12-106-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/5a4b909c6579/1745-6215-12-106-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/654be8d68974/1745-6215-12-106-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/d98092eb7944/1745-6215-12-106-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/9441857b4f57/1745-6215-12-106-4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/5a4b909c6579/1745-6215-12-106-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/654be8d68974/1745-6215-12-106-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/d98092eb7944/1745-6215-12-106-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d259/3113981/9441857b4f57/1745-6215-12-106-4.jpg

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