# Presentation: 520186

## The EDMVS’Draft Work Plan

- Presentation to the EDMVS,
- July 23, 2002

##  Purpose of  Todays WorkPlan 

- Provide the milestones for the assays
- Provide the status of each assay
- Highlight recent additions/changes based on input from the EDMVS

## 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 _                         _Current Status_
- DRP/Protocol                    6/02
- Prevalidation
-       -sectional testes assay        to lab 9/02
-        -cell based assay                 to lab 10/02
-        -multi-chemical study               future
- 	   -Prevalidation Report               future
-  Validation Report	          future

## Pubertals – m&f (Tier I)

-             _Milestone__ _
- DRP equivalent
- Prevalidation
- 	-Single Dose Study
- 	-Multi-chemical & multi-dose Protocols
- 	-Multi-chemical & multi-dose Studies
- 	-Restricted Feeding Study
- 	-Prevalidation Report
- Validation Report

- _Current Status_
-   12/01
-  12/01
- 12/01
- In Lab 
- Today
- future
- future

## Short-Term Fish Reproduction (Tier I)

-         _Milestones_                         _Current Status_
- DRP/Protocol                              3/02
- Prevalidation
- 	   *Short *Fish Repro Study FHM             3/02
- 	   Comparative Study Plans:
- 		-Vitellogenin Methods                    3/02
- 		-Fathead Minnow                           3/02
- 	   Comparative Studies:
- 		-Vitellogenin Methods                   In lab 
- 		-Fathead Minnow                          In lab 
- 	   Prevalidation Report                              future
- Validation Report                        future

## Amphibian Metamorphosis (Tier I)formerly Frog Thyroid 

-      _Milestone_			_Current Status_
- DRP/Protocol        Review  tomorrow
-   ...evaluate utility & future of assay

## ER/AR binding/reporter gene (Tier I)

**	****ICCVAM**
- Scientific Expert Panel	       May 2002 review retrospective validation
- Expert Panel Report                 Sept 2002
**	****EDMVS**
- Updated by ICCVAM                Today

## Aromatase (Tier I)

- <date/time>

**Aromatase** (Tier I)

-      _Milestones _                              _Current Status _
- DRP/Protocol                             3/02
- Prevalidation
-       -placental microsomal assay        In Lab 
-        compare bovine, human, porcine
- 	  -cell based assay                         to lab 9/02
-       -comparison: microsomal &
-                       recombinant assays     to lab 12/02
-       -Prevalidation Report	                future
-  Validation Report	                future

## In Utero   Lactation (Tier ?)

-         _**Milestone **_**                        **_**Current Status**_
- DRP**                          **         12/02
- 	 -Protocol review                        3/02
- Prevalidation
- 	 -Protocol Demo                        In Lab 
-       -Multi-chem study                    future
- 	  -Prevalidation  Report              future
- Validation Report	          future

## Tier II Assays

## Mammalian 2-generation (Tier II) 

-       _Milestone _                     _Current Status_
- DRP/Protocol                    
- Prevalidation
- 	 One-gen. Ext. Protocol                12/01
- 	  Propylthiouracil Study                Today
- 	  One-gen Ext. study                     In Lab 
- 	  Prevalidation Report                   future
- Validation Report            future

## Avian 2-gen. Reproduction (Tier II)  

-      _Milestone _                         _Current Status_
- DRP/Protocol                                12/02
- Prevalidation
- 	    -Avian Dosing Study Plan          3/02
- 	    -Avian Dose Study                To Lab 8/02
- 	    -Protocol demo                         future
- 	    -Prevalidation Report                future
- Validation Report                          future

## Amphibian Dev. & Repro. (Tier II) (aka Amphibian Chronic)

-      _Milestones _                 _Current Status_
- DRP/Protocol                 future 12/02
- Prevalidation
-        -protocol demo              future
-        -multi-chem study          future
- 	   -Prevalidation Report     future
- Validation Report              future

## Mysid Lifecycle (Tier II)aka Invertebrate Chronic 

-      _Milestones _                 _Current Status_
- DRP/Protocol                 tomorrow
- Prevalidation
-       -protocol demo                future
-       -multi-chem study            future
-       -prevalidation Report       future
- Validation Report               future

## Fish Lifecycle (Tier II)aka Fish Chronic  

-         _Milestones _             _Current Status_
- DRP/Protocol               future 12/02
- Prevalidation
-        -protocol demo              future
-        -multi-chem study          future
-        -prevalidation Report     future
- Validation Report 	         future

##  Future EDMVS Meetings  and Topics

- To be Announced in the Near Future

## Future Topics

- Fish Chronic DRP (Tier II)
- Fish Repro. Comparison Studies (Tier I): Vitellogenin
- Avian 2-gen DRP (Tier II)
- Aromatase Prevalidation Report (Tier I)
- Steroidogenesis Protocol demo (Tier I)
- Avian Dose Study
- Amphibian Dev. & Repro. DRP (Tier II)
- Pubertals prevalidation report
- In Utero through lactation protocol demo
- Fish Repro. Comparison Study – fathead minnow
- Hershberger
- Uterotrophic

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