Regulatory Toxicology ยท Carcinogenicity Risk Assessment
Build a scientifically grounded case for whether a two-year carcinogenicity study is needed.
Metisox integrates the available evidence under the ICH S1B(R1) Weight of Evidence approach to assess carcinogenic potential in humans. Our experts connect target biology, pharmacology and toxicology findings to help you determine whether the evidence supports avoiding a long-term study, points to the need for further investigation, or leaves the risk uncertain.
Get an integrated scientific assessment, identify evidence gaps and build a documented rationale for regulatory consultation.
Discuss your CRAICH S1B(R1) enables an integrated Weight of Evidence assessment to inform decisions about long-term carcinogenicity studies. Metisox evaluates the available evidence to help you build a rationale for your next step.
We connect findings across biological mechanisms, animal studies and human data to assess whether observed effects are likely to be relevant to humans.
Our assessment identifies uncertainties and knowledge gaps that may require additional data or investigative studies.
We deliver a structured, expert-written Weight of Evidence assessment that documents the scientific rationale behind your conclusions and supports regulatory consultation.
Our experts evaluate the totality of relevant evidence in line with ICH S1B(R1), rather than relying on an individual study or finding.
Biological function, expression, pathways and the mechanisms that may influence carcinogenic potential.
Target selectivity, interaction networks and off-target activity that may contribute to safety risks.
Findings from chronic studies, including lesions and observations relevant to carcinogenicity.
Evidence of endocrine perturbation and potential hormonal mechanisms.
Available genotoxicity findings and their relevance to human carcinogenic risk.
Evidence of immune effects that may contribute to carcinogenic potential.
We also integrate relevant cancer-model and human evidence, including findings from genetically modified animals, human cancer cell studies and human genetic association studies.
From evidence to a development decision
Our CRA evaluates the overall evidence and helps your team understand its implications.
Document the Weight of Evidence assessment and seek regulatory consultation on whether a long-term study can be avoided.
Build a documented scientific rationale and seek regulatory consultation on the proposed study strategy.
Identify the need for additional evidence or investigative studies, potentially including long-term carcinogenicity studies.
The appropriate next step depends on the complete evidence package and regulatory assessment. Metisox provides the scientific analysis to support that decision; it does not guarantee a particular regulatory outcome.
In one Metisox case, the Weight of Evidence assessment supported taking the evidence to the FDA instead of proceeding with a six-month study.
In another case, mammary findings were traced to a rodent-specific hormonal mechanism, helping distinguish the observed findings from human-relevant risk.
These examples illustrate how integrating mechanistic and species-specific evidence can inform development decisions.
Metisox combines a proprietary scientific knowledge base with expert toxicology assessment. Our experts connect the evidence, evaluate its relevance and document the rationale in a report tailored to your needs.
You receive a full CRA report aligned with the ICH S1B(R1) Weight of Evidence approach, helping your team plan investigations, assess potential risks and prepare for regulatory consultation.
Discuss your compound, available studies and development objectives with Metisox.
Request a CRA assessment