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題名 | 統計方法於藥品品質檢驗上之應用= |
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作者 | 劉仁沛; 周賢忠; |
期刊 | 中國統計學報 |
出版日期 | 19950600 |
卷期 | 33:2 1995.06[民84.06] |
頁次 | 頁169-186 |
分類號 | 412.36 |
語文 | chi |
關鍵詞 | 合量均一度試驗; 溶離度試驗; 崩散度試驗; 現行優良藥品製造標準; 機率下限; 多重階段混合抽樣; Content uniformity testing; Dissolution testing; Disintegration testing; Current good manufacturing practices; CGMP; Probability lower bound; Multiple-stage sampling plan; |
中文摘要 | 為了確保藥品的成份 (identity)、效力 (strength)、品質 (quality) 及純正 (purity),美國、國內及世界各國均對藥品有現行優良藥品製造標準 (Current Good Manufacturing Practices) 的要求。現行良藥製造基準明文規定藥品必須通過美國藥學大典 (United States Pharmacopeia) 內所規定抽樣試驗及通過規格(sampling plan and acceptance criteria)。其中包括合量均一度試驗 (content uniformity testing)、溶離度試驗 (dissolution testing) 及崩散度試驗 (disintegration testing)。本文將對此三種試驗之抽樣方法做一有系統的介紹及分析,並對通過美國藥學大典上接受準則之機率提出估算的方法,以及對各估算方法做一客觀上之比較。 |
英文摘要 | To ensure the identity, strength, quality, and purity of drug products, the United States Food and Drug Adminishation (FDA) reguires that pharmaceutical companies to fulfill with reguirements specified in the Current Good Man ufacturing Practices (CGMP). The CGMP states that all drug products must pass all tests described in the United States Pharmacopia (USP). These tests include content uniformity testing, dissolution testing, and disintegration testing. Each of these three tests consists of a multiple-stage sampling plan and different acceptance criteria at each stage of the test. This paper provides a systematic illustration of each of the three tests and proposes statistical procedures for estimation of the probabilities of passing each test. Comparison of different estionation procedures were examined in a simulation. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。