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.
Assessment of general toxicity
(Q)SAR and read-across
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