Mendeley出力
＜図書＞
Bioequivalence studies in drug development : methods and applications
| 責任表示 | Dieter Hauschke, Volker Steinijans, Iris Pigeot |
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| シリーズ | Statistics in practice |
| データ種別 | 図書 |
| 出版情報 | Chichester, West Sussex : John Wiley , c2007 |
| 本文言語 | 英語 |
| 大きさ | xi, 311 p. ; 25 cm |
| 概要 | Hauschke, Volker Steinijans, biometricians with a German drug company, and Iris Pigeot (preventive research and social medicine, U. of Bremen, Germany) synthesize the findings of studies over the past...couple decades on designing, performing, and evaluating bio-availability and bio-equivalence studies. Writing for clinical pharmacologists, bio-pharmaceutical scientists, regulators, and biometricians in the pharmaceutical industry, they provide many examples using real data, and include some recent methodology, especially on the concepts of population and individual bio-equivalence. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com) 続きを見る |
| 目次 | Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies Basic statistical considerations Assessment of average bioequivalence in the RT/TR design Power and sample size determination for testing average bioequivalence in the RT/TR design Presentation of bioequivalence studies Designs with more than two formulations Analysis of pharmacokinetic interactions Population and individual bioequivalence Equivalence assessment in case of clinical endpoints |
所蔵情報
| 状態 | 巻次 | 所蔵場所 | 請求記号 | 刷年 | 文庫名称 | 資料番号 | コメント | 予約・取寄 | 複写申込 | 自動書庫 |
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理系図3F 数理独自 | HAUS/5/1 | 2007 |
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023212006008320 |
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書誌詳細
| 内容注記 | Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies Basic statistical considerations Assessment of average bioequivalence in the RT/TR design Power and sample size determination for testing average bioequivalence in the RT/TR design Presentation of bioequivalence studies Designs with more than two formulations Analysis of pharmacokinetic interactions Population and individual bioequivalence Equivalence assessment in case of clinical endpoints |
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| 一般注記 | Includes bibliographical references and indexes |
| 著者標目 | *Hauschke, Dieter Steinijans, Volker Pigeot, Iris |
| 件 名 | LCSH:Drugs -- Therapeutic equivalency
全ての件名で検索
MESH:Therapeutic Equivalency MESH:Clinical Trials -- methods 全ての件名で検索 MESH:Drug Design |
| 分 類 | LCC:RM301.45 NLM:QV 38 DC22:615/.19 |
| 書誌ID | 1001237802 |
| ISBN | 0470094753 |
| NCID | BA81045053 |
| 巻冊次 | ISBN:0470094753 ; XISBN:9780470094754 |
| 登録日 | 2009.09.18 |
| 更新日 | 2017.10.03 |