# Presentation: 520185

## 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

## 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 

- Tier I
- Aromatase
- Pubertal male
- Adult 14 –day intact male
- Tier ?
- In Utero through Lactation

## 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)

-    _Milestone _                                  _Meeting Date_
- DRP/Protocol	       June 2002
- Prevalidation
- 		Protocol Demonstration	  Dec 2002
- 		Multi-chemical Study               TBD
- 		Prevalidation Report	   TBD
-  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

## 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

## Amphibian Metamorphosis (Tier I)aka Frog Thyroid 

-      _Milestone_			_Meeting Date_
- DRP/Protocol        June 2002 (?)
- evaluate utility & future of assay by Dec 31, 2002

## 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)

**OECD**
- Completed prevalidation
- Validation Fall 2002
**EDMVS**
- Reviews  OECD’s Integrated Summary Report      March 2003

## Uterotrophic (Tier I)

**OECD**
- Validation process completed
**EDMVS**
- Reviews OECD’s Integrated Summary  March 2003

## 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 ?)

-      _**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

## Tier II Assays

## 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)  

-      _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 

-      _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 

-      _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  

-      _Milestones _                  _Meeting Date_
- DRP/Protocol           June 2002
- Prevalidation
-      Prevalidation Report     May 2003
- 	  (includes multi-chem.)
- Validation Report 	       TBD

##  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

- 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

- 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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