Acrostic
Nitrosamine in silico read-across tool for accurate impurity risk assessment.
Acrostic is our in silico read-across tool, helping you to accurately and efficiently determine acceptable intake (AI) limits for novel nitrosamines, reducing risk and ensuring regulatory compliance.
Leverage a comprehensive dataset and expert knowledge, Acrostic assembles information into a logical and intuitive workflow for optimal compound surrogate selection.
Speak to the team today on how you can confidently assign carcinogenic potency values to your target compounds.
Transparent and reproducible read-across decisions
Utilises a comprehensive database to rapidly assess nitrosamines via an automated read-across workflow.
Scientifically robust methodology validated by experts
Applies tested methodology to surrogate selection, in line with expert understanding and regulatory guidance.
Ensure compliance with ICH M7, FDA, and EMA guidelines
Establish AI limits that comply with regulatory standards while maintaining patient safety.
Struggling with inconsistent data for nitrosamine risk assessments? Acrostic provides a reliable, data-driven solution to reduce uncertainty.
Acrostic enables confident decisions on nitrosamine risk assessments using a published, scientifically robust read-across solution from experts in the nitrosamine field.
- Supports transparent and reproduceable decisions for your ICH M7 assessments.
- Removes the subjectivity of the manual read-across approach.
- Clearly demonstrates why the analogues have been chosen with supporting evidence.
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.