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作者:

Lu, Ying (Lu, Ying.) | Zhang, Zhong-Zhan (Zhang, Zhong-Zhan.) (学者:张忠占) | Chow, Shein-Chung (Chow, Shein-Chung.)

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摘要:

For approval of generic drugs, the U.S. Food and Drug Administration (FDA) requires the evidence of bioequivalence in average bioavailability be provided. This is based on the Fundmental Bioequivalence Assumption from FDA that if two drug products are shown to be bioequivalent, it is assumed that they are therapeutically equivalent and can be used interchangeably. Recently, there are a few statistical considerations for assessing biosimilarity. In this article, we propose a new method based on a frequency estimator to evaluate biosimilarity; the large sample properties of the estimator, the power analysis, and calculation of the sample size are considered. Under a three-arm parallel design, the power comparison between the frequency estimator method and the other existing methods is studied through simulation, and the statistical test based on the proposed method is more powerful than for the other two methods. Simultaneously, we compared the relative performance of the three methods, and the empirical consistency and inconsistency probability are obtained in evaluating the biosimilarity.

关键词:

Bioequivalent Biosimilarity Consistency Frequency estimator method Three-arm parallel design

作者机构:

  • [ 1 ] [Lu, Ying]Beijing Univ Technol, Coll Appl Sci, Beijing 100124, Peoples R China
  • [ 2 ] [Zhang, Zhong-Zhan]Beijing Univ Technol, Coll Appl Sci, Beijing 100124, Peoples R China
  • [ 3 ] [Lu, Ying]Commun Univ China, Beijing, Peoples R China
  • [ 4 ] [Chow, Shein-Chung]Duke Univ, Sch Med, Durham, NC USA

通讯作者信息:

  • 张忠占

    [Zhang, Zhong-Zhan]Beijing Univ Technol, Coll Appl Sci, Beijing 100124, Peoples R China

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来源 :

JOURNAL OF BIOPHARMACEUTICAL STATISTICS

ISSN: 1054-3406

年份: 2014

期: 6

卷: 24

页码: 1280-1297

1 . 1 0 0

JCR@2022

ESI学科: PHARMACOLOGY & TOXICOLOGY;

ESI高被引阀值:142

JCR分区:4

中科院分区:4

被引次数:

WoS核心集被引频次: 3

SCOPUS被引频次: 4

ESI高被引论文在榜: 0 展开所有

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