论文部分内容阅读
评价药品质量高低的测定过程随其要求不同而有所不同。按照美国联邦食品、药品、化妆品管理法规501条款及美国药典(USP)和国家处方集(NF)委员会颁布的法定标准的专题说明,现代商品生产条例[21CFR211,194(a)]规定,用于评介药品质量的测定方法,必须符合一定的准确度和可靠性。条例[21CFR211,194(a)(2)]规定,人们使用美国药典和国家处方集叙述的分析方法,不需要去证实这些方法的准确度和可靠性,而只需
The process of evaluating the quality of a drug varies depending on its requirements. In accordance with Section 501 of the U.S. Federal Food, Drug, Cosmetic Management Code and thematic descriptions of statutory standards promulgated by the U.S. Pharmacopeia (NF) and the National Formulary Board (NF), the Modern Commodity Production Ordinance [21 CFR 211, 194 (a) Evaluation of drug quality measurement methods, must meet certain accuracy and reliability. The Ordinance [21 CFR 211, 194 (a) (2)] states that the analytical methods described by the United States Pharmacopeia and the National Formulary do not require verification of the accuracy and reliability of these methods. Instead,