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Modern Approaches to Estimating the Content of Genotoxic Impurities in Drugs (a Review)
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  • 作者:O. A. Matveeva ; E. L. Kovaleva
  • 关键词:genotoxic impurities ; drugs ; threshold of toxicological concern (TTC)
  • 刊名:Pharmaceutical Chemistry Journal
  • 出版年:2016
  • 出版时间:February 2016
  • 年:2016
  • 卷:49
  • 期:11
  • 页码:765-770
  • 全文大小:97 KB
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    12. Impurities in New Drug Products Q3B(R2) ICH Harmonised Tripartite Guideline; URL: http://​www.​ich.​org/​fileadmin/​Public_​Web Site/ICH_Products/Guidelines/Quality/Q3B_R2/ Step4/Q3B_R2_Guideline.pdf
    13. Guideline on the Limits of Genotoxic Impurities (EMEA/CHMP/QWP/251344/2006); URL: http://​www.​ema . europa.eu/docs/en_GB/document library/Scientific_guideline/2009/09/WC500002903.pdf
    14. Impurities: Guideline for Residual Solvents, Q3C(R5) ICHHarmonised Tripartite Guideline; URL: http://​www.​ich.​org/​fileadmin/​Public_​Web_​Site/​ICH Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdf
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    20. Draft Guidance for Industry, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (CPMP/QWP/159/96 Cor.); URL: http://​www.​fda.​gov/​downloads/​drugs/​guidancecomplian​ce regulatoryinformation/guidances/ucm079235.pdf [http://​www.​fda.​gov/​ohrms/​dockets/​98fr/​fda-2008-d-0629-gdl.​pdf ]
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  • 作者单位:O. A. Matveeva (1)
    E. L. Kovaleva (1)

    1. Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation, 8 Petrovskii Blvd., Moscow, 127051, Russia
  • 刊物类别:Chemistry and Materials Science
  • 刊物主题:Pharmacy
    Pharmacology and Toxicology
    Organic Chemistry
    Russian Library of Science
  • 出版者:Springer New York
  • ISSN:1573-9031
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