Applications of Toxicogenomics in Safety Evaluation and Risk Assessment

PREFACE ix
CONTRIBUTORS xi
1 TOXICOLOGY, "OMICS" TECHNOLOGIES, AND TOXICOGENOMICS: A PRIMER1
Darrell R. Boverhof and B. Bhaskar Gollapudi
2 INTRODUCTION TO HUMAN HEALTH RISK ASSESSMENT 13
Irene Baskerville-Abraham, Alison Willis, Bernard Gadagbui, andLynne T. Haber
3 PRACTICAL CONSIDERATIONS FOR THE APPLICATION OF TOXICOGENOMICSTO RISK ASSESSMENT: EARLY EXPERIENCE, CURRENT DRIVERS, AND A PATHFORWARD 41
Darrell R. Boverhof, David R. Geter, B. Bhaskar Gollapudi, andHeli Hollnagel
4 APPROACHES AND PRACTICAL CONSIDERATIONS FOR THE ANALYSIS OFTOXICOGENOMICS DATA 65
Zhenqiang Su, Hong Fang, Weida Tong, Huixiao Hong, RogerPerkins, and Leming Shi
5 GENOMICS IN IDENTIFYING MUTAGENIC MODE OF ACTION INCARCINOGENESIS 81
Jiri Aubrecht and Ebru Caba
6 APPLICATION OF GENOMICS FOR PREDICTING AND UNDERSTANDING THEMODE OF ACTION FOR NONGENOTOXIC CARCINOGENS 99
Mark R. Fielden
7 GENOMICS IN CHARACTERIZING ENDOCRINE TOXICITY 117
Jorge M. Naciff and George P. Daston
8 STUDYING ORGAN-SPECIFIC TOXICITY USING GENE-EXPRESSIONPROFILING 147
M. Ann Mongan and Hisham K. Hamadeh
9 TOXICOGENOMIC STUDIES IN HUMAN POPULATIONS 177
Cliona M. McHale, Luoping Zhang, Alan E. Hubbard, and Martyn T.Smith
10 TOXICOGENOMICS APPLIED TO ECOLOGICAL RISK ASSESSMENT207
Daniel L. Villeneuve, Dalma Martinovi´c, and Gerald T.Ankley
11 ANALYSIS OF TRANSCRIPTOMIC DOSE-RESPONSE DATA FORTOXICOLOGY AND RISK ASSESSMENT 237
Russell S. Thomas, Longlong Yang, Harvey J. Clewell, and MelvinE. Andersen
12 TOXICOGENOMICS AS A TOOL FOR VALIDATING ANIMAL TO HUMANEXTRAPOLATIONS IN CHEMICAL RISK ASSESSMENT: CONCEPTS, APPLICATIONS,AND CHALLENGES 251
Alan Dombkowski and J. Craig Rowlands
13 TOXICOGENOMICS AND ANIMAL ALTERNATIVES 267
Anne S. Kienhuis, Joost H. M. van Delft, and Jos C. S.Kleinjans
14 TOXICOGENOMICS AND THE REGULATORY FRAMEWORK 293
Kathryn Gallagher, Federico M. Goodsaid, David J. Dix, Susan Y.Euling, Melissa Kramer, Nancy E. McCarroll, Julian R. Preston,Philip G. Sayre, Banalata Sen, Douglas C. Wolf, and William H.Benson
15 STANDARDIZATION OF GENE-EXPRESSION INFORMATION FOR THE SAFETYEVALUATION: ACTIVITIES IN JAPAN 323
Ken-ichi Aisaki and Jun Kanno
16 APPLYING TRANSCRIPTIONAL PROFILING IN DRUG SAFETY EVALUATION331
Lois D. Lehman-McKeeman and William R. Foster
17 REFRAMING THE RISK ASSESSMENT PARADIGM: TOWARD A SYSTEMSBIOLOGY APPROACH 349
Sarah N. Campion and Kim Boekelheide
INDEX 357