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The EDMVS’ Draft Work Plan

The EDMVS’ Draft Work Plan. Presentation to the EDMVS, December 10, 2001. Today’s talk will identify. the assays the major milestones for each assay when the assay milestones will be reviewed by EDMVS the OECD interactions. Tier I Screening Battery recommended for consideration by EDSTAC.

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The EDMVS’ Draft Work Plan

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  1. The EDMVS’Draft Work Plan Presentation to the EDMVS, December 10, 2001

  2. Today’s talk will identify • the assays • the major milestones for each assay • when the assay milestones will be reviewed by EDMVS • the OECD interactions

  3. Tier I Screening Battery recommended for consideration by EDSTAC • Steroidogenesis (EPA) • Pubertal - female (EPA) • Fish reproduction (EPA lead for OECD) • Frog Thyroid (EPA lead for OECD) • Estrogen/Androgen receptor/ binding & reporter gene (ICCVAM for EPA) • Hershberger (OECD) • Uterotrophic (OECD)

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

  5. Tier II Assays recommended for consideration by EDSTAC • Mammalian 2-generation (EPA / OECD) • Avian 2-generation (EPA lead for OECD) • Amphibian chronic (EPA lead for OECD) • Invertebrate Chronic (EPA lead for OECD) • Fish Chronic (EPA lead for OECD)

  6. Steroidogenesis (Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Oct 2002 • Validation Report May 2003 • Integrated Summary May 2003

  7. Pubertal – female (Tier I) Milestone Meeting Date • DRP equivalent Dec 2001 • Prevalidation Report Oct 2002 • Validation Report July 2003 • Integrated Summary July 2003

  8. Fish Reproduction (Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Dec 2002 • Validation Report July 2003 • Integrated Summary July 2003 • OECD interaction: US lead within OECD. Timelines Pending.

  9. Frog Thyroid(Tier I) MilestoneMeeting Date • DRP June 2002 • evaluate utility & future of assay before setting milestone dates

  10. ER/AR binding/reporter gene(Tier I) ICCVAM • DRP, Prevalidation, Validation & Integrated Summary Reports • Expert Consultation May 2002 • Peer Review Fall 2002 EDMVS • reviews ICCVAM Peer Review Report Spring 2003 • provides recommendation on Tier I battery Oct 2003

  11. Hershberger(Tier I) OECD • Completed prevalidation • Validation Fall 2002 EDMVS • reviews Integrated Summary Report Feb 2003 • provides recommendation on Tier I battery Oct 2003

  12. Uterotrophic(Tier I) OECD • Validation process completed EDMVS • reviews Integrated Summary Feb 2003 • provides recommendation on Tier I battery Oct 2003

  13. Aromatase(Tier I) Milestone Meeting Date • DRP March 2002 • Prevalidation Report Oct 2002 • Validation Report May 2003 • Integrated Summary May 2003

  14. Pubertal – male(Tier I) Milestone Meeting Date • DRP equivalent Dec 2001 • Prevalidation Report Oct 2002 • Validation Report July 2003 • Integrated Summary July 2003

  15. Adult 14-day intact male(Tier I) • Development supported by Industry • EDMVS reviews EPA paper comparing results of adult 14-day intact male, pubertal male, and OECD 407 July 2003

  16. In Utero through Lactation(Tier ?) Milestone Meeting Date • DRP Today • Prevalidation Report Dec 2002 • Validation Report Oct 2003 • Integrated Summary Oct 2003

  17. Tier II Assays

  18. Mammalian 2-generation(Tier II) Milestone Meeting Date • DRP none planned • Prevalidation Report Feb 2003 • Validation Report 2004 • Integrated Summary 2004 OECD interaction: Likely to be US lead within OECD. Timelines pending: OECD acknowledges need to revise guideline, but will finish revisions currently in process first.

  19. Avian 2-generation(Tier II) Milestone Meeting Date • DRP March 2002 • Prevalidation Report 2004 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  20. Amphibian Chronic(Tier II) Milestone Meeting Date • DRP Oct 2002 • Prevalidation Report May 2003 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  21. Invertebrate Chronic(Tier II) Milestone Meeting Date • DRP June 2002 • Prevalidation Report May 2003 • Validation Report 2004 • Integrated Summary 2004 • OECD interaction:US lead within OECD. Timelines pending.

  22. Fish Chronic(Tier II) Milestone Meeting Date • DRP March 2002 • Prevalidation May 2003 • Validation 2004 • Integrated Summary 2004 • OECD interaction: US lead within OECD. Timelines pending.

  23. Assays and Milestones for Future EDMVS Meetings March 2002 • Steroidogenesis DRP • Fish Reproduction DRP • Aromatase DRP • Avian 2-gen DRP • Fish Chronic DRP

  24. June 2002 • Frog Thyroid DRP • Invertebrate DRP 

  25. October 2002 • Steroidogenesis Preval. Report • Pubertal - female Preval. Report • Pubertal - male Preval. Report • Aromatase Preval. Report • Amphibian DRP

  26. December 2002 • Fish repro. Preval. Report • In utero  Lactation Preval. Report February 2003 • Hershberger Integrated Summary • Uterotrophic Integrated Summary • Mammalian 2-gen Preval. Report

  27. May 2003 Validation & Integrated Summary Reports: • Steroidogenesis • Aromatase Prevalidation Reports: • Amphibian Chronic • Invertebrate Chronic • Fish Chronic

  28. July 2003 Validation & Integrated Summary Reports: • Pubertal - male • Pubertal - female • Fish Reproduction Comparison Paper – adult 14-day intact male, pubertal male, and OECD 407

  29. October 2003 • In Utero through Lactation Validation & Integrated Summary Report • Tier I Screening Battery Composition Review

  30. - 2004 - Validation & Integrated Summary Reports: • Mammalian 2-gen • Amphibian Chronic • Invertebrate Chronic • Fish Chronic Avian 2-gen Preval., Validation & Integrated Summary Reports

  31. March Agenda • Steroidogenesis DRP • Fish Reproduction DRP • Aromatase DRP • Avian 2-gen DRP • Fish Chronic DRP • Other Issues: Low dose

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