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治疗等效性研究：统计学考量

Therapeutic equivalence investigations: statistical considerations.

作者信息

Röhmel J

机构信息

Federal Institute for Drugs and Medical Devices, Berlin, Germany.

出版信息

Stat Med. 1998;17(15-16):1703-14. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1703::aid-sim972>3.0.co;2-g.

DOI:10.1002/(sici)1097-0258(19980815/30)17:15/16<1703::aid-sim972>3.0.co;2-g
PMID:9749441
Abstract

Therapeutic equivalence studies still present problems to regulatory reviewers from many perspectives. This paper is intended to discuss some of these concerns from the statistical viewpoint. There are, however, also some newer approaches which may be particularly useful for the investigation of therapeutic equivalence.

摘要

治疗等效性研究从许多角度来看仍然给监管审评人员带来问题。本文旨在从统计学角度讨论其中一些问题。然而，也有一些更新的方法可能对治疗等效性的研究特别有用。

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