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Pubertals andOne-generation Extension
Overview of questions
• Does the fire raise significant concerns?
• Should the EPA bring the pubertal and one-gen extension study designs to EDMVS before moving forward?
• Should EPA halt prevalidation studies that have been begun in parallel with DRP development, until EDMVS approves the DRPs?
Does the fire raise significant concerns?
• Is Bisphenol A an issue?• Does EDMVS wish to see the final
report of the independent review panel? yes, before moving forward yes, but go ahead in the meantime no, the fire is not a significant issue
Fire considerations
• If fire report is brought to EDMVS one-gen study will not start Nov. 14 pubertal array study may not begin in
early January
Pubertals
• Single-dose data• Multi-dose
study design, chemical & dose selection
• Multiple-chemical array study design, chemical & dose selection
Pubertal considerations
• December agenda, unavailability of alternative dates. Extend Dec. meeting?
• Review time for single-dose data (not available in soft copy)
• Study design is currently based on the expert advice of developers of assay (EPA/RTP)
One-generation extension
• New protocol, never performed• Developed by EPA/RTP• Reviewed by P. Foster, CIIT• Proof-of-concept only; multi-chemical
study will be done later
Details: Pubertals (1)
Details: Pubertals (2)
• Male and female are parallel but separate• Potential delay due to recent fire in lab
Upcoming EDMVS meetings:December 2001
• Detailed Review Papers aromatase steroidogenesis in utero through lactation
• Need for pubertal DRP?• Low dose
Upcoming EDMVS meetings:March 2002
• Detailed Review Papers on OECD assays Fish reproduction Fish chronic Avian chronic Invertebrate Frog screen and chronic (?)
• Fish repro screen vs. vitellogenin• Dose-setting in validation studies• Restricted feeding study protocol
Upcoming EDMVS meetings:June 2002
• Pubertal prevalidation single-dose multiple-dose array of chemicals
• Mammalian two-gen prevalidation thyroid study one-gen extension
• Steroidogenesis prevalidation• Aromatase prevalidation
Questions for discussion tomorrow
• Is the logic of the plan sound?• Are the time estimates reasonable?• Is a Mammalian 2-gen DRP needed?• Is a Mammalian 2-gen practicality
study needed?• Should we be concerned about the
fire in the lab?