Developmental toxicology: new directions workshop: refining testing strategies and study designs

Area of Science:

• Developmental and Reproductive Toxicology
• Risk Assessment
• In Vitro Toxicology

Background:

• A workshop convened by the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) focused on "Developmental Toxicology-New Directions."
• The workshop aimed to enhance the relevance and predictivity of animal studies for human health risk assessment.
• Key areas included refining existing animal testing and exploring novel, non-animal-based approaches.

Purpose of the Study:

• To summarize presentations and discussions on advancing developmental toxicology testing.
• To identify strategies for improving the effectiveness and efficiency of toxicity assessments.
• To explore the integration of new technologies and non-animal testing methods.

Main Methods:

• Summarized five presentations covering study refinement, comparative embryology, pharmacokinetics, genetically modified models, and biologics testing.
• Documented discussions on refining animal studies using toxicokinetics, dose selection, tiered strategies, and alternative models.
• Captured discussions on non-animal testing paradigms, including signal definition, exposure translation, validation, and bridging the gap to risk assessment.

Main Results:

• Participants agreed on the effectiveness of current testing but acknowledged resource intensiveness.
• Significant discussion centered on refining animal testing through data integration and improved study design.
• Exploration of non-animal testing paradigms highlighted the need for validation and clear definitions for adverse effects.

Conclusions:

• Improved effectiveness in developmental toxicity testing is achievable through methodological advancements.
• Integrating toxicokinetic data and employing tiered testing strategies can refine animal studies.
• Further development and validation of non-animal testing paradigms are crucial for future risk assessment.