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IATA: Integrated Approaches to Testing and Assessment

Integrated Approaches to Testing and Assessment (IATA) represent a paradigm shift in toxicology - moving from single-test decisions to weight-of-evidence approaches that combine multiple information sources including NAMs, computational predictions, and existing data.

IATA Components

• In Silico Methods - (Q)SAR models, read-across, molecular modeling
• In Chemico Assays - Chemical reactivity tests (e.g., DPRA)
• In Vitro NAMs - Cell-based assays, organoids, organ-on-chip
• Existing Data - Historical testing, literature, exposure information
• Expert Judgment - Structured assessment by qualified toxicologists

IATA Case Studies

• Skin Sensitization DA - OECD TG 497 combines DPRA + KeratinoSens + h-CLAT
• Eye Irritation - Bottom-up/top-down testing strategies using multiple NAMs
• Developmental Toxicity - Integrating stem cell assays with (Q)SAR
• Systemic Toxicity - Multi-organ chip data combined with PBPK modeling

Building an IATA

1. Define the regulatory question and context of use
2. Gather all available existing information
3. Identify relevant NAMs for the endpoint
4. Develop data integration strategy (Defined Approach or case-by-case)
5. Apply weight-of-evidence assessment
6. Document uncertainty and confidence
7. Reach regulatory conclusion

Regulatory Recognition

IATA approaches are recognized by FDA, EPA, ECHA, and OECD for various endpoints. The flexibility of IATA enables NAMs acceptance even before formal validation, supporting innovation while maintaining safety standards.