Acrostic
Confidently determine acceptable intake limits for novel nitrosamines and support systemic toxicity read-across, for impurity risk assessment compliance.
Assess novel nitrosamine and extractables and leachables (E&L) risks quickly using Acrostic, our in silico read-across solution, which integrates curated datasets, expert knowledge and structured workflows to support defensible safety decisions.
Speak with our team to learn how Acrostic provides a clear, expert-led framework for efficiently assigning safety limits to your target compounds.
Generate transparent and reproducible read-across decisions
Reduce reliance on manual read-across and rapidly assess nitrosamines and E&L compounds using curated datasets, structured workflows and expert-led scientific logic.
Understand the science behind every analogue selection
Review automated expert-authored arguments confidence scores, and similarity measures across mechanistic, structural, metabolic and physicochemical properties.
Ensure compliance with regulatory expectations
Support ICH M7, FDA and EMA-aligned nitrosamine assessments, and build transparent read-across justifications for systemic toxicity, including for E&L compounds, in line with ICH Q3E and ISO 10993.
Produce submission ready reports ready for expert review
Automatically document your surrogate selection, scientific rationale and cohort of concern assessment within a clear, reproducible workflow.
Struggling with inconsistent data for impurity and E&L risk assessments?
Acrostic provides a powerful, data-driven solution confidently aligned with regulatory guidance.
Acrostic provides a powerful, data-driven read-across framework to reduce uncertainty and support confident, regulatory-aligned decisions.
Acrostic helps you:
- Justify assessment analogue selection with embedded scientific arguments and confidence scores
- Remove subjectivity in manual read-across assessments
- Quickly assess nitrosamines and E&L compounds and document your workflow and rationale
- Export clear reports that document your rationale and support expert review
Reduce read-across assessment time by up to 90% compared to manual workflows*.
Request your Acrostic demonstration today:
*Consult Lhasa scientists have demonstrated up to 90% time savings compared with fully manual read-across workflows
Conducting your nitrosamine impurity and E&L read-across assessments
Before conducting your nitrosamine or E&L risk assessment, you will need to address the following:
Do you have access to all of the relevant information to assess your potentially toxic compounds?
- Can you confidently make a safe decision about this substance and mitigate risks?
- How much uncertainty are you or the regulatory agency willing to accept?
- Can you defend the decision you have made to regulatory agencies?
If the answer is no, use read-across assessment to:
- Quickly identify a surrogate compound with sufficient data
- Check that the surrogate chemical contains similar structural, mechanistic, metabolic or physicochemical features associated with the toxic endpoints, you’re worried about
- Automatically search and reference curated datasets to support acceptable intake limits or systemic toxicity read-across, including for E&L compounds
To deliver efficient, reliable results, the Acrostic read-across workflow for calculating safety limits for nitrosamines and systemic toxicity, follows these principles:
Access to curated toxicology datasets
Acrostic retrieves carcinogenicity and in vitro data for potential analogues from Vitic, LCDB, ECHA, ToxValDB and Munro datasets, alongside Lhasa data-sharing initiatives and your own in-house data where available.
Selects potential compound surrogates
Selects compounds based on based on mechanistic, structural, metabolic and physicochemical similarity, supported by Derek Nexus alerts and Meteor metabolic predictions.
Rank your most suitable analogues
Ranks analogue suitability for deriving acceptable intake limits or supporting systemic toxicity justification according to transparent similarity scoring and expert-guided ranking criteria.
Confident decision-making for regulatory submissions
Acrostic produces a regulatory-ready report, across ICH M7, emerging ICH Q3E, FDA, EMA and ISO 10993 - aligned assessments allowing for expert review to justify decisions made.
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.