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含量均匀度检查方法的比较与评价 被引量:7

Comments and Evaluation on the Statistical Characteristics of Content Uniformity Tests
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作者 陶巧凤
出处 《中国药品标准》 CAS 2005年第4期32-34,共3页 Drug Standards of China
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  • 1[1]Williams RL, Adams WP, Poochikian G, Hauck WW. Content Uniformity and Dose Uniformity: Current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products.Pharm Res, 2002; 19: 359-366
  • 2[2]Martin JM,Farinha A,Uniformity of dosage units-comparative study of methods and specifications between Eur. Pharm. 3rd and USP 23. J. Pharm and Biomed Analysis;18(1998) :487-495
  • 3[8]Flann B. Comparison of criteria for content uniformity. J.Pharm. Sci. 1974; 63:183
  • 4[9]Tonglei Li, Donner AD, Choi CY, Frunzi GP, Morris KR, A Statistical Support for Using Spectroscopic Methods to Validate the Content Uniformity of Solid Dosage Forms. J. Pharm. Sci. 2003 ;92:1526

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