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The EDMVS’ Draft Work Plan

The EDMVS’ Draft Work Plan. Presentation to the EDMVS, March 25, 2002. Purpose of WorkPlan. Review the assays Provide update of EDMVS meeting dates Identify the special studies involved with the milestones for each assay Provide future EDMVS meeting topics.

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The EDMVS’ Draft Work Plan

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  1. The EDMVS’Draft Work Plan Presentation to the EDMVS, March 25, 2002

  2. Purpose of WorkPlan • Review the assays • Provide update of EDMVS meeting dates • Identify the special studies involved with the milestones for each assay • Provide future EDMVS meeting topics

  3. Tier I Screening Battery recommended for consideration by EDSTAC • Steroidogenesis • Pubertal - female • Short Term Fish Reproduction • Amphibian Metamorphosis aka Frog Thyroid • Estrogen/Androgen receptor binding or reporter gene • Hershberger • Uterotrophic

  4. Alternative Assaysrecommended for consideration by EDSTAC Tier I • Aromatase • Pubertal male • Adult 14 –day intact male Tier ? • In Utero through Lactation

  5. Tier II Assays recommended for consideration by EDSTAC • Mammalian 2-generation • Avian 2-gen. Reproduction • Amphibian Development and Repro. aka Amphibian Chronic • Mysid Lifecycle aka Invertebrate Chronic • Fish Lifecycle aka Fish Chronic

  6. Steroidogenesis (Tier I) Milestone Meeting Date • DRP/Protocol June 2002 • Prevalidation Protocol Demonstration Dec 2002 Multi-chemical Study TBD Prevalidation ReportTBD • Validation Report TBD

  7. Milestone DRP equivalent Prevalidation -Single Dose Study -Multi-chemical Protocol -Multi-dose Protocol -Restricted Feeding Protocol -Restricted Feeding Study -Prevalidation Report Validation Report Meeting Date Dec 2001 Done (12/01) Done (12/01) Done (12/01) June 2002 March 2003 March 2003 TBD Pubertals – m&f (Tier I)

  8. Milestones DRP/Protocol Prevalidation -A Short …Method…Fish Repro Tox …using Fathead Minnow Comparative Study Plans: -Vitellogenin Methods -Fathead Minnow Comparative Studies: -Vitellogenin Methods -Fathead Minnow -Prevalidation Report (multi-chem) Validation Report Meeting Dates March 2002 March 2002 March 2002 March 2002 March 2003 March 2003 July 2003 TBD Short-Term Fish Reproduction (Tier I)

  9. Amphibian Metamorphosis(Tier I)aka Frog Thyroid MilestoneMeeting Date • DRP/Protocol June 2002 (?) • evaluate utility & future of assay by Dec 31, 2002

  10. ER/AR binding/reporter gene(Tier I) ICCVAM • Scientific Expert Panel May 2002 EDMVS • Updated by ICCVAM June 2002 • Lab. Validation Dec 2002

  11. Hershberger(Tier I) OECD • Completed prevalidation • Validation Fall 2002 EDMVS • Reviews OECD’s Integrated Summary Report March 2003

  12. Uterotrophic(Tier I) OECD • Validation process completed EDMVS • Reviews OECD’s Integrated Summary March 2003

  13. Aromatase(Tier I) Milestones Meeting Date • DRP/Protocol March 2002 • Prevalidation -Prevalidation Report Dec 2002 (protocol demo, multi-chem. study) • Validation Report TBD

  14. In Utero Lactation(Tier ?) Milestone Meeting Date • DRP/Protocol Done (12/01) -Protocol review March 2002 • Prevalidation -Protocol Demo March 2003 -Prevalidation Report TBD (includes multi-chem) • Validation Report TBD

  15. Tier II Assays

  16. Mamm. 2-gen. Repro.(Tier II) Milestone Meeting Date • DRP/Protocol none planned • Prevalidation One-gen. Ext. Protocol done (12/01) Propylthiouracil (PTU) Study June 2002 One-gen Ext. study TBD Prevalidation Report TBD • Validation Report TBD

  17. Avian 2-gen. Reproduction(Tier II) Milestone Meeting Date • DRP/Protocol Dec 2002 • Prevalidation Avian Dosing Study Plan March 2002 Avian Dose Study Dec 2002 Protocol demo TBD Prevalidation Report (multi-chem) TBD • Validation Report TBD

  18. Amphibian Dev. & Repro. (Tier II)aka Amphibian Chronic Milestones Meeting Date • DRP/Protocol Dec 2002 • Prevalidation -Prevalidation Report TBD (protocol demo, multi-chem study) • Validation Report TBD

  19. Mysid Lifecycle(Tier II)aka Invertebrate Chronic Milestones Meeting Date • DRP/Protocol June 2002 • Prevalidation Prevalidation Report May 2003 (includes multi-chem) • Validation Report TBD

  20. Fish Lifecycle (Tier II)aka Fish Chronic Milestones Meeting Date • DRP/Protocol June 2002 • Prevalidation Prevalidation Report May 2003 (includes multi-chem.) • Validation Report TBD

  21. Future EDMVS Meeting Topics June 2002 • Amphibian Metamorphosis DRP (Tier I) • Steroidogenesis DRP (Tier I) • Pubertals –Restricted Feeding Protocol (Tier I) • Invertebrate DRP (Tier II) • Fish Chronic DRP (Tier II) • Mammalian 2-gen – PTU special study • General Dose Setting • Status Report: ER/AR

  22. December 2002 • Aromatase Prevalidation Report (Tier I) • ER/AR Validation Report (Tier I) • Steroidogenesis Protocol demo (Tier I) • Avian 2-gen. DRP (Tier II) • Avian Dose Study • Amphibian Dev. & Repro. DRP (Tier II)

  23. March 2003 or so • Pubertals m/f Prevalidation Report (Tier I) • In Utero Lactation Protocol Demo. (Tier ?) • Hershberger • Uterotrophic • Fish Repro. Comparison Studies (Tier I): • Fathead Minnow • Vitellogenin

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