Lhasa Limited shared knowledge shared progress
Home > Library > Search the Library > Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure
Publications

Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure

Glowienke S; Araya S; Lovsin-Barle E;

The use of in silico methods to predict mutagenicity is increasingly acknowledged and implemented in the recently released ICH M7 guideline for the limitation of DNA reactive impurities. In this study we investigate the possibility to apply (quantitative) structure-activity-relationships ((Q)SARs) during hazard identification to reduce the number of Ames tests needed for a hazard assessment of IM while maintaining high standards of protection of the employees. Ames test outcomes for 188 substances used in the pharmaceutical production were compared with their in silico predictions using two different (Q)SAR methodologies (knowledge based and statistical) complemented by expert knowledge. 

Visit site
  • 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.