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    政大機構典藏 > 商學院 > 統計學系 > 期刊論文 >  Item 140.119/66450


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    題名: 生物統計在藥品開發暨生產過程之應用研究
    其他題名: The Application of Biopharmaceutical Statistics in Drug Development
    作者: 周賢忠;林慧
    Chow, Shein-Chung;Ju, Huey L.
    貢獻者: 統計系
    關鍵詞: 非臨床試驗 ; 化驗方法確認 ; 定比放大 ; 生產程序確認 ; 藥品安定性
     Nonclinical trials ; Assay validation ; Scale-up ; Process validation; Drug stability
    日期: 1995-06
    上傳時間: 2014-06-04 12:24:03 (UTC+8)
    摘要: 生物統計在製藥界的應用研究主要導源於美國政府對藥品的規定與要求。根據美國在1906年通過的 “聯邦食品及藥物法案” (Pure Food and Drug Act)，本主詳細描述了美國政府對藥品管理的一些法令規章、規範、以及施行細則。這些法令規章、規範以及施行細則被製藥界廣泛的應用以確保所生產的藥品具有優良藥品應具備的特性。我們對統計在藥品開發及生產過程中的應用做了深入的探討與評估。同時，我們也列舉了一些經由評估所引發在藥品開發及生產的過程中，生物統計在非臨床試驗的未來研究方向。
    For the development of pharmaceutical compounds, the Current Good Manu facturing Practice (CGMP) requires that valid sampling plans acceptance criteria, and statistical methods be employed to ensure the identity, strength, quality, and purity of the developed pharmaceutical compounds according to the United States Pharmacopeia and the National Formulary (USP/NF) standards. As a result, the application of biopharmaceutical statistics has played an important role in drug development in the areas of both clinical and nonclinical. In this paper, we will only focus on the app1ication of biopharmaceutical statistics in nonclinical area of drug development. We first provide an overview of some regulatory requirements in nonclinical area of drug development. These regulatory requirements include Code of Federal Regulations (CFR), CGMP, USP /NF, and the U. S. Food and Drug Administration (FDA) guidances and guidelines. Pertaining to these regulatory requirements, we discuss several statistical issues that often occur in nonclinical area of drug development such as assay development and validation, scale-up design and analysis, process validation, and stability. In addition, we also provide several potential research topics in these areas.
    關聯: 中國統計學報,33(2),129-151
    資料類型: article
    顯示於類別:[統計學系] 期刊論文

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