Use of “Big Data” to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products

被引:0
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作者
Lesley Reeve
Paul Baldrick
Andrew Newell
Scott Templeton
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[1] Covance Laboratories Ltd,
关键词
Big Data; ICH S2(R1); Micronucleus test (MNT); Comet assay; Stand-alone in vivo genotoxicity assays; Combined in vivo genotoxicity assays;
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页码:764 / 769
页数:5
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  • [1] Use of "Big Data" to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products
    Reeve, Lesley
    Baldrick, Paul
    Newell, Andrew
    Templeton, Scott
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (04) : 764 - 769