EOGRTS: Study Design Considerations
Charles River has been designing and conducting EOGRTS since 2014, completing over 130 across its global facilities to date. With extensive experience in running these large and complex studies, our scientists are frequently asked to present on the practicalities of the design at scientific conferences and to provide input on industry task forces.
Prior to study initiation, it is useful to have some background data on reproductive endpoints such as spermatogenesis (testicular histopathology) for males and ovarian integrity (histopathology) for females. Data from repeat-dose studies or short-term endocrine disrupter screening assays can also be used to evaluate effects on male and female reproductive organs.
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Generating EOGRTS Data on the Test Substance
Aside from the typical considerations of dose route, levels and frequency, vehicle, and species, a thorough review of existing data is beneficial for OECD 443 studies. This could include physicochemical data, toxicokinetics, toxicodynamic properties, structure-activity relationships, in vitro metabolic processes, results of previous toxicity studies, and structural analogs. Other useful information includes:
- Data that estimates internal dosimetry
- Data that evaluates potential dose-dependent saturation of kinetic processes
- Metabolite profiles
- Concentration-time courses
EOGRTS provide data on the effects of repeated exposure to a test substance during all phases of the reproductive cycle. In particular, the study will provide information on potential effects on the reproductive system and on development, growth, survival, and functional endpoints of subsequent generations.
Although large and complex, the revised study design provides information that addresses endpoints which historically required several separate studies, thereby requiring significantly fewer animals to generate data1.
Choosing the Right EOGRTS Partner
When choosing a partner for your DART and EOGRTS programs it's important to consider experience and expertise. Charles River is a leading provider of OECD 443 programs and has the regulatory and industry knowledge gained over 10 years to ensure your EOGRTS programs are planned and executed in the most efficient way, delivering reliable data to keep your development on track.
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1Cooper RL, Lamb JC, Barlow SM, Bentley K, Brady AM, Doerrer NG, Eisenbrandt DL, Fenner-Crisp PA, Hines RN, Irvine LFH, Kimmel CA, Koeter H, Li AA, Makris SL, Sheets LP, Speijers G, Whitby KE. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol. 2006 Jan;36(1):69–98. PMID: 16708695