Acrostic
Confidently determine nitrosamine acceptable intake (AI) limits using read-across tool for impurity risk assessment compliance.
Assess novel nitrosamine risks quickly using Acrostic, our in silico read-across solution, which integrates comprehensive datasets and expert knowledge into intuitive workflows – saving you time through automation and facilitated decision-making.
Speak with our team to learn how Acrostic provides a clear, expert-led framework for efficiently assigning carcinogenic potency values to your target compounds.
Generate transparent and reproducible read-across decisions
Mitigate the need for manual read-across and utilise our comprehensive database to rapidly assess nitrosamines.
Understand the science behind every AI limit calculation
Review automated expert-authored arguments and confidence scores for each potential surrogate.
Ensure compliance with ICH M7, FDA, and EMA guidelines
Produce reports that automatically document your surrogate selection, rationale and 'cohort of concern' assessment.
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 an Acrostic demonstration
Conducting your nitrosamine impurity risk assessment
Before conducting your nitrosamine 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 nitrosamine 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, you may decide not to test your target compound in a certain assessment, and instead embark on a read-across assessment to determine:
- Can you identify a surrogate compound with sufficient data?
- Does this chemical also contain structural features associated with the toxic endpoints you’re worried about?
- Or does it belong to a class of compounds with known toxicity?
Instead of embarking on manual read-across methods, companies and regulators worldwide are conducting efficient nitrosamine read-across analysis with Acrostic. To deliver efficient, reliable results, the Acrostic read-across workflow for calculating nitrosamine AI limits, follows these principles:
Access to curated nitrosamine impurity databases
Acrostic retrieves carcinogenicity and in vitro data for potential analogues from Vitic, the Lhasa Complex Nitrosamines data sharing initiative, and LCDB.
Selects potential compound surrogates
Selects compounds based on matching structural features, as proposed in Lhasa publications defining carcinogenic potency levels for NDSRIs.
Rank your suitable nitrosamine analogues
Ranks analogue suitability according to focused similarity, physico-chemical and pharmacokinetic properties.
Confident decision-making for ICH M7 submissions
Based on user selection Acrostic produces a regulatory-ready report, 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.