In silico assessments of mutagenicity for extractables & leachables and medical devices 

The regulatory guidelines for E&L and medical devices follow the ICH M7 drug impurity guidance for assessing and controlling DNA reactive extractable and leachables. In the absence of adequate experimental data, the results from two complementary QSAR methodologies, one expert rule-based and the second statistical-based, is combined to support an initial hazard classification and reduce the number of required experimental in vitro studies.

Skin sensitisation is also an endpoint of interest.

 

The scientists at ToxNavigation have more than 25 years of experience in in silico modelling to predict the effects of chemicals on humans and in the environment and can generate reliable toxicity data in silico by combining results from (Q)SAR models, chemical categories, grouping and read-across

Unique screening service

When an analytical chemist uses mass spectrometry for compound elucidation they start with a number of probable isomers. Final structural confirmation is time consuming causing a significant delay in assessing mutagenicity and sensitization. ToxNavigation can provide a cost effective screening service for the isomers for mutagenicity and skin sensitisation.

Genotoxicity profiling

Assessment of general toxicity

(Q)SAR and read-across

experience

  • 25 years of experience with in silico  modelling

  • Multiple relevant models are used to increase confidence in the derived toxicity estimates

  • Expert selection of tools and methods in agreement with the official guidelines

  • In silico results complementary to in vitro results

COST EFFECTIVE & FLEXIBLE

  • Free feasibility study

  • In silico methods - lower cost compared to in vitro methods

  • Rapid access to several free and commercial tools

  • Service tailored to your needs (e.g. internal decision making or safety evaluation)

DELIVERY & CUSTOMER SUPPORT

  • Feasibility study typically delivered in two days

  • Study report typically delivered within two weeks

  • 24 hour reactivity to client questions

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ToxNavigation Ltd. is a company registered in England and Wales. Registered number: 11114004. Registered office: Mole View, 158 Bridge Road, East Molesey, Surrey, KT8 9HW.