Lhasa Limited shared knowledge shared progress
Home > Library > Search the Library > An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7
Publications

An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7

pdf fileNye WE; Shannon-Little AL; Yeo D; Johnston LA; Harding A; Williams RV;

A classification workflow tool has been developed by Lhasa Limited to aid in the submission of impurities under the ICH M7 guideline. The workflow uses two in silico tools, Derek and Sarah Nexus, alongside experimental Ames and carcinogenicity data to predict an ICH M7 class. This workflow tool presents the classifications in a submission ready format, while still allowing the user to supplement the workflow with their own data. The workflow currently provides an ‘Inconclusive’ classification for chemicals that are not well defined by the guideline. This poster describes how impurities are classified using the workflow, in order to facilitate discussion regarding whether those compounds with a predicted class of ‘inconclusive’ are being treated appropriately.

Download

Additional Documents

    • Linked In
    • Twitter

    © 2022 Lhasa Limited | Registered office: Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Tel: +44 (0)113 394 6020
    VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

    Apart from the free survey software, we also have access to QuestionPro's free survey templates . We've found many of them useful and powerful to collect insights from various stakeholders of our organization.