Powerful read-across for N-nitrosamine risk assessments
Accurately predict novel nitrosamine acceptable limits (AI) through automated workflows and scientifically robust justification.
Acrostic helps you build definitive and defensible risk assessments for novel nitrosamines, especially for those that fall outside of the Carcinogenic Potency Categorisation Approach (CPCA).
But how does it tackle the specific challenges you face?
We sat down with our in-house experts, Principal Scientist, David Ponting, PhD. and Application Scientist Jessica Halliday, for a Q&A session.
Watch below to see them answer your most common questions.
An expert Q&A on confident nitrosamine read-across
David Ponting, PhD., is a Principal Scientist at Lhasa Limited. David has co-authored several peer-reviewed publications fundamental to the industry’s understanding of nitrosamine risk. In this direct Q&A, he and Application Scientist, Jessica Halliday address the everyday challenges scientists face when moving beyond standard CPCA thresholds for N-nitrosamines.
Watch the discussion to gain read-across insights into building a scientifically sound and defensible impurity risk assessment. Learn how to justify surrogate selection with confidence, navigate data reliability, and construct a scientifically robust argument, structured to align with ICH M7, FDA, and EMA guidelines.
Your key nitrosamine read-across questions answered
How can I streamline complex nitrosamine assessments confidently?
Acrostic automates search across multiple sources at once, including Vitic toxicity data, the Lhasa Carcinogenicity database and your in-house data, to instantly identify relevant surrogates, saving days of manual data gathering.
How do I build robust regulatory justifications?
The workflow generates a well-reasoned expert review, providing a scientifically robust, pre-formulated argument that you can then build upon with your own expert rationale for regulatory justification.
Can I trust the data for analogue selection?
Each surrogate is paired with data reliability scoring, through quality, similarity and translatability, giving you clear reasoning to choose the most scientifically robust analogue for your final choice.
Why should I trust Acrostic’s read-across approach?
Acrostic combines scientific expertise from Lhasa Limited with insights from our member community to create a robust read-across solution that is practically applied to real-world nitrosamine risk assessment challenges.
Struggling with inconsistent data for nitrosamine risk assessments?
Acrostic provides a powerful, data-driven solution confidently aligned with regulatory guidance.
Acrostic provides the framework for a transparent, defensible and reproducible workflow. Using a published, scientifically robust read-across solution from experts in the nitrosamine field, Acrostic helps you:
- Justify assessment analogue selection with embedded scientific arguments and confidence scores
- Remove the subjectivity of a manual read-across approach
- Quickly document your entire workflow and rationale into a report, ready for expert review.
Define acceptable intake limits for your novel, untested nitrosamines today.
Request your Acrostic demonstration
A structured workflow for a defensible assessment
Move from a complex N-nitrosamine query to a conclusion you can stand behind with confidence. Click through to see how Acrostic guides you through a logical and transparent workflow.
Initiate your assessment by defining your query nitrosamine compound. Acrostic immediately accesses trusted internal and external sources to present a comprehensive set of relevant analogues.
Analyse the evidence for each potential analogue. Transparent reliability scores and clear ranking filters enable your expert judgment, allowing you to select the most scientifically appropriate surrogate for your query.
Acrostic generates a ‘well-reasoned expert review’, providing a complete scientific justification for your selection. This robust foundation allows you to efficiently add, edit and document your own expert insights into the final risk assessment.
Convert your scientific argument into a quantitative result. Acrostic calculates the final AI limit, ensuring a traceable and reproducible regulatory limit for your compound risk assessment.
Export a single, traceable report that documents every step of your assessment. The comprehensive output provides a defensible record for your regulatory submission, structured to align with ICH M7, FDA, and EMA guidelines.
Explore our other in silico solutions that can help you monitor the risk of formation, and toxicological concern of nitrosamine impurities: Mirabilis, Zeneth, Derek Nexus, Sarah Nexus, Vitic, and the Lhasa Carcinogenicity Database.