OECD Test Guideline Updates 2025: The Impact Upon DART Study Designs and the Future Landscape of Omics

In June 2025, updated versions of several Organization for Economic Co-operation and Development (OECD) Test Guidelines were published. This has impacted the study design of three key Test Guidelines for developmental and reproductive toxicology (DART) studies: OECD 421, OECD 422 and OECD 443.

This webinar will examine the implications of these changes to the Test Guidelines concerning their impact on study design itself. Emphasis will be placed on the changes to the study design of the OECD 443 Extended One Generation Reproductive Toxicity Study, a large and complex DART study. In addition, updates to the OECD 421 and 422 Test Guidelines signify a shift in the regulatory landscape to a relatively new concept for regulatory studies: omics evaluations.

Here, the featured speaker will highlight the changes to the OECD Test Guidelines and what these changes could mean for the OECD 421 and 422 study designs. The speaker will also describe the context in which these Test Guideline changes have been made by exploring how omics measurements may become a fundamental aspect of regulatory studies in the future.

Speaker

Steve Renaut, Associate Director, DART, LabCorp

Steve Renaut has been active in the field of Developmental and Reproductive Toxicology (DART) for over 25 years, having started his professional career as a DART Study Director in 1999. As Associate Director for DART, he is responsible for the day-to-day operation and performance of the Study Directors within the DART Study Direction group at Labcorp.

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