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Recovery Animals in Toxicology Studies: An Innovation and Quality Consortium Perspective on Best Practices With Case

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Summary

This study surveyed industry practices for recovery animals in safety studies, finding opportunities to reduce animal use by excluding recovery groups when scientifically justified. Recommendations align with toxicologic pathology guidelines, aiming to decrease animal use without compromising human risk assessment quality.

Keywords:
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Area of Science:

  • Pharmaceutical Sciences
  • Toxicology
  • Animal Welfare

Background:

  • Regulatory guidance for nonclinical safety studies allows diverse approaches for recovery animals.
  • Opportunities exist to reduce recovery animal use by utilizing scientific and regulatory data.
  • Previous attempts to standardize recovery practices have not been consistently applied in the pharmaceutical industry.

Purpose of the Study:

  • To survey current industry practices for evaluating reversibility/recovery in repeat-dose toxicity studies.
  • To identify challenges and opportunities for refining the use of recovery animals.
  • To propose recommendations for decreasing animal use while maintaining risk assessment quality.

Main Methods:

  • A working group surveyed industry practices regarding recovery animal use in repeat-dose toxicity studies.
  • Case studies were analyzed to highlight strategies and refinements.
  • Discussions focused on aligning practices with Society of Toxicologic Pathology recommendations.

Main Results:

  • Industry practices show increasing alignment with recommendations to exclude recovery cohorts by default.
  • Minimizing recovery groups (e.g., control and one dose level) and excluding controls are key strategies.
  • Decisions on recovery group exclusion and timing are based on indication, modality, and scientific factors.

Conclusions:

  • Implementing recommended strategies can significantly decrease the use of recovery animals.
  • Reducing animal use is achievable without negatively impacting the quality of human risk assessment.
  • A weight-of-evidence approach supports informed decisions on recovery animal inclusion and timing.