政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/79651
English  |  正體中文  |  简体中文  |  Post-Print筆數 : 27 |  全文筆數/總筆數 : 113648/144635 (79%)
造訪人次 : 51595815      線上人數 : 941
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
搜尋範圍 查詢小技巧：
  • 您可在西文檢索詞彙前後加上"雙引號"，以獲取較精準的檢索結果
  • 若欲以作者姓名搜尋，建議至進階搜尋限定作者欄位，可獲得較完整資料
    •  進階搜尋
    政大機構典藏 > 商學院 > 統計學系 > 期刊論文 >  Item 140.119/79651


    請使用永久網址來引用或連結此文件: https://nccur.lib.nccu.edu.tw/handle/140.119/79651


    題名: On tier method for assessment of individual bioequivalence
    作者: Ju, Huey L.
    貢獻者: 統計系
    關鍵詞: Prescribility;Switchability;Bioavailability;Interval hypothesis
    日期: 1997
    上傳時間: 2015-12-14 17:33:45 (UTC+8)
    摘要: The bioavailability and bioequivalence between drug products has become an important subject in drug development. The average bioavailability of the test (T) and the reference (R) products is currently specified in the FDA guidelines to be used for assessing the bioequivalence of the drug products. However, it has been recognized that the safety for the substitution of a reference drug product with a test drug product in patients, whose concentration may have been titrated to a steady efficacious and safe level, could be a concern. Therefore, it is suggested that individual bioequivalence within each subject be assessed to assure the safety of the drug switchability. This paper examines the statistical properties of TIER procedure that Anderson and Hauck (1) proposed to assess individual bioequivalence. It is shown that Anderson and Hauck`s procedure could be improved by imposing some distribution assumption such as lognormal distribution for assessment of individual bioequivalence. This paper also compares the relative performance of the individual bioequivalence based on TIER procedure and the average bioequivalence based on two one-sided tests procedure suggested by Schuirmann (2). The relationship between equivalence limits for the improved TIER procedure and average bioequivalence is also examined.
    關聯: Journal of Biopharmaceutical Statistics, Volume 7, Issue 1, pages 63-85
    資料類型: article
    DOI 連結: http://dx.doi.org/10.1080/10543409708835170
    DOI: 10.1080/10543409708835170
    顯示於類別:[統計學系] 期刊論文

    文件中的檔案:

    檔案 描述 大小格式瀏覽次數
    index.html0KbHTML2562檢視/開啟


    在政大典藏中所有的資料項目都受到原著作權保護.


    社群 sharing

    著作權政策宣告 Copyright Announcement
    1.本網站之數位內容為國立政治大學所收錄之機構典藏，無償提供學術研究與公眾教育等公益性使用，惟仍請適度，合理使用本網站之內容，以尊重著作權人之權益。商業上之利用，則請先取得著作權人之授權。
    The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

    2.本網站之製作，已盡力防止侵害著作權人之權益，如仍發現本網站之數位內容有侵害著作權人權益情事者，請權利人通知本網站維護人員(nccur@nccu.edu.tw)，維護人員將立即採取移除該數位著作等補救措施。
    NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.
    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - 回饋