Supporting your non-genotoxic impurity (NGI) qualification
If your impurity is not mutagenic or carcinogenic, the impurity levels may still need to be justified, to demonstrate that the level of impurity present is safe. Below a threshold, non-genotoxic impurities (NGIs) are accepted but where they are present at a level above the threshold, an impurity qualification is required. NGI qualification requires a weight of evidence assessment, which we can help you with.
Vitic is a source of high-quality, peer-reviewed public and proprietary toxicity data, covering a broad range of endpoints. Vitic can help you to understand if there is existing data available for your compound.
Search for data across a broad range of endpoints
Vitic is a database that contains toxicity data for endpoints beyond carcinogenicity and genotoxicity – such as acute toxicity, skin sensitisation, irritation and developmental and reproductive toxicity – which can help to assess the broader toxicity of your impurities.
Access high-quality public and proprietary data
The toxicity data held within Vitic comes from a wide variety of sources, Vitic contains expert curated, high-quality and peer-reviewed data, from both published and unpublished sources.
Find similar structural analogues using substructure or similarity searches
Where there is no exact match within Vitic, you can make use of the substructure or similarity search functionality.
Derek Nexus is an expert, knowledge-based prediction software that can help you to establish if there is a toxicity hazard associated with your compound.
Derek Nexus highlights
Access expert Structure-Activity Relationship (SAR) knowledge for over 70 endpoints
Derek Nexus contains Structure-Activity Relationship (SAR) knowledge for a broad range of endpoints – including acute toxicity, skin sensitisation, irritation and developmental and reproductive toxicity, and more. The SAR knowledge is derived from both public and proprietary member data sources and is updated as new data becomes available.
Identify any toxicophores highlighting possible hazard
The expert comments associated with a Derek Nexus alert can help you to decide if this compound structure is a concern or not.
Understand the SAR behind predictions
The scientific comments which accompany a Derek Nexus alert will describe the chemical and biological mechanisms of action where possible.
Vitic and Derek Nexus can help you with the qualification of impurities from your API or drug product, to determine whether any additional studies are necessary, in relation to the below relevant guidance.
We are delighted to announce that our paper ‘Using adverse outcome pathways to contextualise (Q)SAR predictions for reproductive toxicity – A case …
In our earlier instalments of the Lhasa blog, we have discussed the latest regulatory insights presented by the U.S. Food and Drug …