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    題名: 藥劑個體生體相等與藥劑互用安全之研究
    其他題名: Individual Bioequivalence and Drug Interchangeability.
    作者: 林慧
    貢獻者: 統計學系
    關鍵詞: 處方性;互換性;生體可用率;生體相等性;藥物互換性
    Prescribility;Swichability;Bioavailability;Bioequivalence;Drug interchangeability
    日期: 1995
    上傳時間: 2014-09-02 17:31:57 (UTC+8)
    摘要: 藥劑可用(Bioavailability)和藥劑生體相等(Bioequivalence)的研究,在今日製藥界成為極重要之課題,美國食品藥物管理局(Food and Drug Administration,FDA)在準則中指出,藥物間相等性的評估應使用平均生體可用性(Average bioavailability)。然而,藥物的互換性(Interchangeability)包括處方性(Prescribility)及交換性(Switchability)。而後者並無法經由平均生體相等來評估。於是個體生體相等學說(Individual bioequivalence)有日漸取代平均生體相等學說的趨勢。本計畫探討了Anderson and Hauck(1990)所提出評估個體生體相等方法的統計特性,並加入母數分配假設以改進其缺失。本計畫亦比較其與Schuirmann(1987)所提出以評估平均相等方法之表現(Performance)。個體生體相等及平均生體相等界限之關係亦在本計畫中有深入之探討。
    The bioavailability and bioequivalence studies between drug products has become an important subject in drug development. The mean 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 be assessed by comparing the distributions of the two drug products within each subject to assure the drug swichability. This paper compares the performance of the individual bioequivalence and average bioequivalence by using the procedures proposed by Anderson and Hauck (1990) and Shirmann (1987). It modifies the procedure of Anderson and Hauck (1990) by imposing lognormal distribution assumption to better assess the individual bioequivalence. The corresponding equivalence limits for the individual and average bioequivalences are also presented.
    關聯: 行政院國家科學委員會
    計畫編號NSC84-2331-B004-001
    資料類型: report
    顯示於類別:[統計學系] 國科會研究計畫

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