Using historical control data in bioassays for regulatory toxicology

Area of Science:

• Toxicology
• Bioassay
• Regulatory Science

Background:

• Historical control data (HCD) are pooled control group responses from bioassays.
• HCD are essential for quality assurance, identifying toxicological effects, and addressing statistical challenges in regulatory studies.

Purpose of the Study:

• To review classical and novel approaches for utilizing HCD.
• To identify current issues in HCD practice and provide recommendations for improvement.
• To stimulate discussion on incorporating uncertainty and tiered criteria for HCD in toxicological assessments.

Main Methods:

• Review of existing literature on HCD utilization.
• Identification of practical challenges and statistical considerations in HCD application.
• Discussion of potential revisions to HCD inclusion/exclusion criteria.

Main Results:

• Current practices for HCD use are analyzed, highlighting areas for enhancement.
• Recommendations for improved HCD integration into toxicological assessments are proposed.
• The importance of HCD in a weight-of-evidence approach is emphasized.

Conclusions:

• Effective use of HCD is critical for robust toxicological bioassays.
• Further discussion is needed regarding uncertainty and tiered criteria for HCD.
• Optimizing HCD utilization enhances the reliability of regulatory toxicology studies.