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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
The EDMVS’Draft Work Plan

Presentation to the EDMVS,

March 25, 2002


Purpose of workplan
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


Tier i screening battery recommended for consideration by edstac
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


Alternative assays recommended for consideration by edstac
Alternative Assaysrecommended for consideration by EDSTAC

Tier I

  • Aromatase

  • Pubertal male

  • Adult 14 –day intact male

    Tier ?

  • In Utero through Lactation


Tier ii assays recommended for consideration by edstac
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


Steroidogenesis tier i
Steroidogenesis (Tier I)

Milestone Meeting Date

  • DRP/Protocol June 2002

  • Prevalidation

    Protocol Demonstration Dec 2002

    Multi-chemical Study TBD

    Prevalidation ReportTBD

  • Validation Report TBD


Pubertals m f tier i

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)


Short term fish reproduction tier i

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)


Amphibian metamorphosis tier i aka frog thyroid
Amphibian Metamorphosis(Tier I)aka Frog Thyroid

MilestoneMeeting Date

  • DRP/Protocol June 2002 (?)

  • evaluate utility & future of assay by Dec 31, 2002


Er ar binding reporter gene tier i
ER/AR binding/reporter gene(Tier I)

ICCVAM

  • Scientific Expert Panel May 2002

    EDMVS

  • Updated by ICCVAM June 2002

  • Lab. Validation Dec 2002


Hershberger tier i
Hershberger(Tier I)

OECD

  • Completed prevalidation

  • Validation Fall 2002

    EDMVS

  • Reviews OECD’s Integrated Summary Report March 2003


Uterotrophic tier i
Uterotrophic(Tier I)

OECD

  • Validation process completed

    EDMVS

  • Reviews OECD’s Integrated Summary March 2003


Aromatase tier i
Aromatase(Tier I)

Milestones Meeting Date

  • DRP/Protocol March 2002

  • Prevalidation

    -Prevalidation Report Dec 2002

    (protocol demo, multi-chem. study)

  • Validation Report TBD


In utero lactation tier
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



Mamm 2 gen repro tier ii
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


Avian 2 gen reproduction tier ii
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


Amphibian dev repro tier ii aka amphibian chronic
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


Mysid lifecycle tier ii aka invertebrate chronic
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


Fish lifecycle tier ii aka fish chronic
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


Future edmvs meeting topics
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


December 2002
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)


March 2003 or so
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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