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Juvenile Bone Toxicity: Study Considerations, Regulations, and Techniques for Assessment.
LaRonda Morford1, Ronee Baracani2, Aurore Varela3
11539Lilly, Indianapolis, IN, USA.
International Journal of Toxicology
|December 15, 2022
Summary
This symposium provided recommendations for evaluating juvenile bone toxicity, covering study designs, imaging, biomarkers, and regulatory considerations. It highlighted methods for assessing bone health and growth in developmental toxicology studies.
Area of Science:
- Toxicology
- Developmental Biology
- Pharmacology
Background:
- Juvenile bone toxicity is a critical concern in drug development.
- Existing study designs may not adequately capture in-life effects.
- International Council for Harmonisation (IHC) guidelines are evolving.
Purpose of the Study:
- To present recommendations for evaluating juvenile bone toxicity.
- To discuss imaging modalities, biomarkers, and regulatory issues.
- To update on advancements in developmental toxicology study designs.
Main Methods:
- Symposium presentations covering study design, statistical power, and species selection.
- Review of imaging techniques, including micro-Computed Tomography (micro-CT).
- Discussion of potential biomarkers for bone toxicity assessment.
Main Results:
- Pathologies in past studies were briefly reviewed.
- Tools for monitoring bone toxicity, healing, and remodeling were presented.
- Micro-CT applications in embryo-fetal development (EFD) and pre- and postnatal development (PPND) were detailed.
Conclusions:
- Optimized study designs are needed for juvenile bone toxicity evaluation.
- Advanced imaging and biomarkers can enhance assessment.
- Regulatory perspectives are crucial for implementing new strategies.
