Methods2AOP: A Collaboration to Strengthen the Integration of Test Methods into the Adverse Outcome Pathway Framework

Area of Science:

• Toxicology
• Regulatory Science
• Computational Biology

Background:

• The Adverse Outcome Pathway (AOP) framework organizes mechanistic toxicology data for regulatory assessment.
• Current integration of test method information, especially New Approach Methods (NAMs), into the AOP-Wiki is suboptimal.
• This limits the AOP framework's utility in regulatory decision-making.

Purpose of the Study:

• To review the work of the Methods2AOP collaboration in addressing the gap of test method integration within the AOP framework.
• To propose methods for enhancing the role and inclusion of test data within the AOP knowledgebase.
• To facilitate the regulatory acceptance and adoption of NAMs.

Main Methods:

• Review of the Methods2AOP collaboration's initiatives and outputs.
• Conceptual proposal for integrating structured test method information into the AOP knowledgebase.
• Utilizing ontologies for standardization and structuring of information.

Main Results:

• The Methods2AOP collaboration emphasizes linking detailed test method information to the AOP framework.
• A conceptual model demonstrates similarities between key event components and structured methods information.
• Proposed use of ontologies to standardize information, enhancing interoperability and reusability.

Conclusions:

• Implementing Methods2AOP recommendations will increase clarity and transparency of test method descriptions.
• This standardization supports regulatory acceptance and wider adoption of NAMs.
• The effort fosters a more robust and transparent AOP system aligned with scientific and regulatory goals.