IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

Area of Science:

• Toxicology
• Chemical Risk Assessment
• Predictive Science

Background:

• Toxicology is shifting from observational to predictive science.
• New Approach Methodologies (NAMs) aim to reduce, refine, or replace animal testing.
• In vitro to in vivo extrapolation (IVIVE) is a key NAM with increasing literature support.

Purpose of the Study:

• To provide operational definitions for IVIVE.
• To review IVIVE applications for common toxicity endpoints.
• To discuss the implications of IVIVE in regulatory decision-making.

Main Methods:

• Literature review of IVIVE publications over the past decade.
• Analysis of IVIVE applications across various toxicity endpoints.
• Examination of IVIVE's role in regulatory agencies and international organizations.

Main Results:

• A significant increase in IVIVE publications over the last ten years.
• Examples of IVIVE application for specific toxicity endpoints are presented.
• IVIVE is increasingly influencing decision-making in chemical risk assessment.

Conclusions:

• IVIVE is a crucial tool for advancing predictive toxicology.
• Continued development and regulatory qualification of IVIVE methods are essential for replacing animal models.
• IVIVE supports efficient and ethical chemical safety evaluations.