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    Jan 2017
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    Regulatory Toxicology and Pharmacology
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Distinguishing between expert and statistical systems for application under ICH M7

Barber CG; Hanser T; Judson PN; Williams RV;

The ICH M7 guidelines for the identification of DNA reactive (genotoxic) impurities draw a distinction between expert and statistical systems.  This paper describes factors that can help discriminate between the two systems and how to avoid co-developing them in a way that undermines their independence or the orthogonality expected by the guidelines.


• Defining characteristics of expert and statistical in silico systems are presented.
• Mechanisms to ensure both systems complement each other are described.
• Risks of in silico models that may be inappropriate for ICH M7 are highlighted.



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