- Highlighted Item:
- Publication Date:Jan 2017
- Reference:Regulatory Toxicology and Pharmacology
- Publication Type:Paper
- Scientific Area:
- Industry Type:
Distinguishing between expert and statistical systems for application under ICH M7
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.