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Androgen Receptor (AR) Binding Assay Peer Review Materials

EPA announced in a July 2007 Federal Register Notice (PDF) (4 pp, 67K, About PDF) the approach it intends to take for conducting peer reviews of the Tier 1 screening assays and Tier 2 testing assays that are being validated.  As described in the Federal Register Notice, peer review materials will be posted as they become available. Materials may include the documents to be peer reviewed, background documents, the charge to the peer reviewers, and reports that summarize the results of peer reviews. Peer review materials for the Androgen Receptor (AR) Binding Assay can be accessed below:

You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.

Charge to Peer Reviewers

Charge to Peer Reviewers (PDF) (3 pp, 23K)

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Integrated Summary Report

Integrated Summary Report for the Validation of the Androgen Receptor Binding Assay as a Potential Screen in the Endocrine Disruptor Screening Program Tier-1 Battery (PDF) (236 pp, 9.1M)

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Background Documents

Appendix 1. Androgen Receptor Binding Assay Background Review Document

ICCVAM Background Review Document. Current Status of Test Methods for Detecting Endocrine Disruptors: In Vitro Androgen Receptor Binding Assays (PDF) (222 pp, 804K)

Appendix 2. Validation of an Androgen Receptor Binding Assay: Establish Interlaboratory Variability Using a “Standard” Cytosol Preparation

Overview Report: Validation of an Androgen Receptor Binding Assay Using a “Standard” Cytosol Preparation (PDF) (1 pp, 16K)

Statistical Analysis Report: Validation of an Androgen Receptor Binding Assay Using a “Standard” Cytosol Preparation (PDF) (15 pp, 603K)

Draft Report Prepared by IIT Research Institute (PDF) (47 pp, 1.8M)

Audited Draft Final Report Prepared by Southern Research Institute (PDF) (153 pp, 8.2M)

Draft Report Prepared by In Vitro Technologies, Inc. (PDF) (121 pp, 1.5M)

Draft Report Prepared by ABC Laboratories, Inc. (PDF) (115pp, 2.6M)

Validation of an Androgen Receptor Binding Assay Prepared by Battelle Richland (PDF) (95 pp, 628K)

Appendix 3. Validation of an Androgen Receptor Binding Assay: Establish Inter-Laboratory Variability Using Cytosol Prepared in Each Participating Laboratory

Overview Report: Validation of an Androgen Receptor Binding Assay Using Cytosol Prepared in Each Participating Laboratory (PDF) (2 pp, 18K)

Statistical Analysis Report: Validation of an Androgen Receptor Binding Assay Using Cytosol Prepared in Each Participating Laboratory (PDF) (15 pp, 511K)

Audited Draft Final Report Prepared by Southern Research Institute (PDF) (173 pp, 25.4M)

Draft Report Prepared by In Vitro Technologies, Inc. (PDF) (136 pp, 1.9M)

Draft Report Prepared by ABC Laboratories, Inc. (PDF) (91 pp, 2.5M)

Validation of an Androgen Receptor Binding Assay prepared by Battelle Richland (PDF) (97 pp, 1.1M)

Appendix 4. Validation of an Androgen Receptor Binding Assay: Test Coded Chemicals

Overview Report: Validation of an Androgen Receptor Binding Assay Using Test Coded Chemicals (PDF) (2 pp, 18K)

Statistical Analysis Report: Validation of an Androgen Receptor Binding Assay Using Test Coded Chemicals (PDF) (28 pp, 1.4M)

Audited Draft Final Report Prepared by Southern Research Institute (PDF) (269 pp, 63.5M)

Draft Report Prepared by In Vitro Technologies, Inc. (PDF) (151 pp, 2.1M)

Draft Report Prepared by ABC Laboratories, Inc. (PDF) (152 pp, 2.9M)

Validation of an Androgen Receptor Binding Assay prepared by Battelle Richland (PDF) (193 pp, 1.3M)

Appendix 5. Validation of an Androgen Receptor Binding Assay: Database Expansion

Overview Report: Validation of an Androgen Receptor Binding Assay - Database Expansion (PDF) (1 pp, 16K)

Statistical Analysis Report: Validation of an Androgen Receptor Binding Assay - Database Expansion (PDF) (41 pp, 1.5M)

Draft Report on Database Expansion: Validation of an Androgen Receptor Binding Assay prepared by Battelle Richland (PDF) (309 pp, 2.8M)

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Peer Review Results

Peer Review Results for the AR Binding Assay (PDF) (77 pp, 311K)

EPA Response to Peer Review Comments (PDF) (9 pp, 47K)

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