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A Derek and OECD Toolbox based comprehensive toxicological risk assessment for all significant endpoints including Genotoxicity, Acute toxicity, Repeated Dose Toxicity, Carcinogenicity, and Local Toxicity effects for a single molecule.
This report contains quantitative toxicology endpoints estimated using read-across or regression analysis, to supplement predictions generated from expert-rules based software like Derek Nexus.
A standard Ames mutagenicity report according to ICH M7 (R4) guidelines using the LeadScope Genotoxicity Suite.
Forced degradation analysis
The forced degradation products of a given formulation will be generated using Zeneth. This report will include degradants of the active molecules and excipients and the reactive derivatives of any of the shared components with other molecules in the formulation.
The human body metabolites will be generated for a single molecule using Meteor Nexus and analysis to check if any of these metabolites show any structural toxicity alerts.
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