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Current Regulatory and Scientific Issues
in Genetic Toxicology


Invited Speakers Presentations

David M. DeMarini, Ph.D.
U.S. Environmental Protection Agency, Research Triangle Park, NC

Review of 30 Years of Research on the Occurrence, Genotoxicity, and Carcinogenicity of Disinfection By-products in Drinking Water: A Roadmap for Research

Vasily N. Dobrovolsky, Ph.D.
NCTR/FDA

Pig-A Gene - A New Endogenous Target for Detection of in vivo Mutation Using Flow Cytometry

Rosalie K. Elespuru
Food and Drug Administration, CDRH

ILSI and ICH Battery Maintenance: Increased Voltage or Hazard Identification Short Circuit?


Patricia Escobar, Ph.D.
Boehringer-Ingelheim Pharmaceuticals, Inc.

New Applications of the Comet Assay in Genetic Toxicology Testing

Sheila M. Galloway, Ph.D.
Merck Research Laboratories, West Point, PA

Rationale for the Proposed Revisions to ICH S2 Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Elmar Gocke, Ph.D.
F. Hoffmann-La Roche Ltd

Risk Assessment of Genotoxic Impurities: The Case of EMS


B. Bhaskar Gollapudi, Ph.D.
The Dow Chemical Company

The ILSI-HESI Initiative on Relevance and Follow-up of Positive Results in in vitro Genetic Toxicity Testing (IVGT)

David Jacobson-Kram, Ph.D., D.A.B.T.
OND, CDER, FDA

Changes to ICH S2: Why They Are Needed, How They Will Help

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Michelle O. Kenyon
Pfizer Global Research and Development

Risk Management Strategies for Ames Mutagens

Channa Keshava, Ph.D.
National Center for Environmental Assessment, Office of Research and Development
U.S. Environmental Protection Agency

Use of Genotoxicity Data in Mode of Action Analysis for Human Health Risk Assessment

Dan D. Levy, Ph.D.
Food and Drug Administration, CFSAN

What Makes an In Vitro Positive Irrelevant? A Case Study with Eugenol

James T. MacGregor, Ph.D., D.A.B.T.
Toxicology Consulting Services

Genetic Toxicology Assessment: Balancing Regulation and Science

Martha Moore, Ph.D.
US-FDA, NCTR

Overview of the Latest Recommendations for Interpreting Data from the Mouse Lymphoma Assay

Paul Nioi, Ph.D.
The Schering-Plough Research Institute

Prediction of Non-Genotoxic Carcinogenesis in Rats Using Changes in Gene Expression Following Acute Dosing

James F. Rusling, Ph.D.
University of Connecticut
Chemistry Department

Electro-optical Toxicity Screening Arrays and Complementary Biocolloid LC-MS Method


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