Development of genotoxic impurities guidelines and their impact on regulatory review

被引：0
|
作者：
Klenke, Elisabeth [1 ]
机构：
[1] Swissmedic, Bern, Switzerland
来源：
TOXICOLOGY LETTERS | 2013年 / 221卷
关键词：
RISK;
D O I：
10.1016/j.toxlet.2013.06.053
中图分类号：
R99 [毒物学（毒理学）];
学科分类号：
100405 ;
摘要：
引用
收藏
页码：S15 / S15
页数：1
相关论文
共 50 条
  • [21] Genotoxic Impurities in Drug Substances
    Snodin, David
    [J]. ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2009, 13 (03) : 409 - 409
  • [22] Genotoxic impurities: A quantitative approach
    Yuabova, Zhanna Y.
    Holschlag, David R.
    Rodriguez, Shirley A.
    Qin, Cindy
    Papov, Vladimir V.
    Qiu, Fenghe
    McCaffrey, John F.
    Norwood, Daniel L.
    [J]. JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, 2008, 31 (15) : 2318 - 2330
  • [23] Determination of Genotoxic Impurities in Pharmaceuticals
    David, Frank
    Alegre, Maria Rambla
    Vanhoenacker, Gerd
    Sandra, Pat
    [J]. LC GC EUROPE, 2013, : 31 - 34
  • [24] Impact of impurities on water electrolysis: a review
    Becker, Hans
    Murawski, James
    Shinde, Dipak V.
    Stephens, Ifan E. L.
    Hinds, Gareth
    Smith, Graham
    [J]. SUSTAINABLE ENERGY & FUELS, 2023, 7 (07) : 1565 - 1603
  • [25] Proactive evaluation of possible genotoxic impurities during the early stages of drug development
    Srinivasan, Aloka
    [J]. Pharmaceutical Technology, 2019, 2019
  • [26] Proactive evaluation of possible genotoxic impurities during the early stages of drug development
    Srinivasan, Aloka
    [J]. Pharmaceutical Technology, 2019, 2019
  • [27] Genotoxic impurities: strategies for balanced approach
    Elder, D. P.
    [J]. JOURNAL OF PHARMACY AND PHARMACOLOGY, 2006, 58 : A36 - A37
  • [28] Risk assessment of genotoxic impurities in pharmaceuticals
    Humfrey, Charles
    [J]. TOXICOLOGY LETTERS, 2009, 189 : S39 - S39
  • [29] Introduction to the Genotoxic Impurities Special Feature
    Teasdale, Andrew
    [J]. ORGANIC PROCESS RESEARCH & DEVELOPMENT, 2015, 19 (11) : 1435 - 1436
  • [30] FDA Designations for Therapeutics and Their Impact on Drug Development and Regulatory Review Outcomes
    Kesselheim, A. S.
    Darrow, J. J.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2015, 97 (01) : 29 - 36
12345