Molecular Biological Markers for Toxicology and Risk Assessment

Molecular Biological Markers for Toxicology and Risk Assessment

1st Edition - June 8, 2016

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  • Author: Bruce Fowler
  • Hardcover ISBN: 9780128095898
  • eBook ISBN: 9780128019016

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Molecular Biological Markers for Toxicology and Risk Assessment provides an introduction to the exciting field of biomarkers and their use in toxicology and risk assessment. In recent years, new classes of molecular biomarkers capable of detecting early manifestations of ongoing chemical-induced cell injury and cell death have been developed as a result of advances in analytical chemistry, molecular biology, and computational modeling. The interplay between these emergent tools of science has resulted in new insights into initial mechanisms of chemical-induced toxicity and carcinogenicity. Molecular Biological Markers for Toxicology and Risk Assessment guides the reader through a broad range of molecular biological markers, including the "omic" biomarkers, and provides an examination of the various elements in the evolution of these modern tools. It then explores possible ways in which these markers may be applied to advance the field of chemical risk assessment. Since molecular biomarkers and related technologies are inherently complex, the book concludes with a section on risk communication in order that readers may appreciate both the strengths and limitations of molecular biological marker approaches to risk assessment practice.

Key Features

  • Introduces the use of molecular biomarkers to detect toxic effects of chemicals as early as possible
  • Provides an accessible overview of this emerging, interdisciplinary field, to best inform decision making in chemical and pharmaceutical safety
  • Includes a section on risk communication of these complex concepts, essential for effective risk assessment
  • Provides new insights into the initial mechanisms of chemical-induced toxicity and carcinogenicity


Professional toxicologists, risk assessors, and regulators

Table of Contents

    • Preface
    • Chapter 1: Molecular Biological Markers for Toxicology and Risk Assessment
      • Abstract
      • 1. Introduction
      • 2. Enzyme Activity–Based Biomarkers
      • 3. Currently Measured Biomarker Proteins
      • 4. Omic Biomarkers
      • 5. Computational Toxicology Approaches
      • 6. Application of Molecular Biomarkers for Risk Assessment
    • Chapter 2: Historical Development of Biomarkers
      • Abstract
      • 1. Biomarkers of Exposure
      • 2. Exposome and Biomarkers of Exposure
      • 3. Specific Biomonitoring Analytical Methodologies
      • 4. Biomonitoring Studies
      • 5. Biological Monitoring for Chemical Metabolites and Interconverted Chemical Species
      • 6. Clinical Biomarkers—Current Usages and Prospects for the Future
      • 7. Biomarker Modifying Factors and Identification of Populations at Risk
      • 8. Technical Advances in Instrumentation
      • 9. Basic Scientific Biomarker Validation Approaches
    • Chapter 3: Computational Toxicology
      • Abstract
      • 1. Introduction
      • 2. Data Mining Approaches—Getting an Overview of the Current Molecular Biomarker Literature
      • 3. Some Useful and Publically Available Data Resources
      • 4. International Public Health Databases
      • 5. European Union
      • 6. Chemical Risk Assessment Resources in Selected Countries and States
      • 7. WHO Chemical Risk Assessment Network
      • 8. Computational Toxicology Approaches to Biomarker Development and Validation
      • 9. Toxicology Testing Resources in Europe
      • 10. Computational Tools for Capturing the Biomarker Literature
      • 11. Computational Approaches for Assisting in Molecular Biomarker Development
      • 12. Applications of Computational Methods for Guiding Biological Marker Research—A Summary
    • Chapter 4: Omic Biological Markers
      • Abstract
      • 1. Introduction
      • 2. Statistical/Bayesian Approaches for Delineating Biomarkers
      • 3. Proteomics
      • 4. Metabolomics/Metabonomics
      • 5. Current Applications of Omic Biomarkers for Risk Assessment Purposes
    • Chapter 5: Validation of Biological Markers for Epidemiological Studies
      • Abstract
      • 1. Introduction
      • 2. Molecular Biomarker Validation Through Correlation With Other Biological Endpoints
      • 3. Application of Computational Modeling Approaches for Extrapolating From In Vitro or Experimental Animal Model Systems for Molecular Biomarker Validations
      • 4. Ease of Application for Risk Assessment Practice
      • 5. Correlations at the Population Level and Population-Based Risk Assessment Studies via NHANES
      • 6. Applications to Risk Assessment Practice
    • Chapter 6: Technical Translational Analysis of Molecular Biomarker Data
      • Abstract
      • 1. Introduction
      • 2. Modeling and Interpretation of Data
      • 3. Integration of Diverse Data Sets
      • 4. Validation of Biological Marker Data With Other Outcome Data
    • Chapter 7: Quality Assurance/Quality Control (QA/QC) for Biomarker Data Sets
      • Abstract
      • 1. Introduction
      • 2. General Definitions
      • 3. Discussion of QA/QC Definition
      • 4. Sample Handling for Biomarker Development
      • 5. Intrinsic Variability of Measured Biomarker Endpoints
      • 6. Equipment Maintenance, Internal Standards, and Chain of Custody for Assurance of Data Quality
      • 7. Data Analysis and Archival Storage Needs
      • 8. Summary and Conclusions
    • Chapter 8: Translation of Biomarkers for Human Clinical and Epidemiological Studies
      • Abstract
      • 1. Introduction
      • 2. Clear Definitions of Biomarker Terminology
      • 3. Biomarkers for Epidemiological Studies
      • 4. Biomarkers for Chemical Mixture Risk Assessments
      • 5. Merging Chemical Exposure Data and Genetic Inheritance Data for Risk Assessments
      • 6. Summary and Conclusions
    • Chapter 9: Risk Communication of Molecular Biomarker Information
      • Abstract
      • 1. Introduction
      • 2. Information Mapping Technology
      • 3. Translation of Molecular Biomarker Data for Societal Decision Making
      • 4. Summary and Conclusions
    • Chapter 10: Future Research Directions
      • Abstract
      • 1. Further Validation of Biological Markers for Humans and Barriers to Acceptance Into Risk Acceptance Practice
      • 2. Application of Artificial Intelligence Computer Programs for Integrating Diverse Data Sets and Facilitating Risk Assessments
      • 3. Calculation of Acceptable Exposure Levels for Chemicals on an Individual or Mixture Basis
      • 4. Incorporation of Individual Genotypes Into Biological Marker-Based Risk Assessments
      • 5. Getting on the Rising Road—Some Suggestions
    • Index

Product details

  • No. of pages: 164
  • Language: English
  • Copyright: © Academic Press 2016
  • Published: June 8, 2016
  • Imprint: Academic Press
  • Hardcover ISBN: 9780128095898
  • eBook ISBN: 9780128019016

About the Author

Bruce Fowler

Bruce Fowler
Dr. Fowler began his scientific career at the National Institute of Environmental Health Sciences prior to becoming Director of the University of Maryland System-wide Program in Toxicology and Professor at the University of Maryland School of Medicine. He then served as Associate Director for Science in the Division of Toxicology and Environmental Medicine at Agency for Toxic Substances and Disease Registry (ATSDR). He is currently a private consultant and Co-owner of Toxicology Risk Assessment Consulting Services (TRACS), LLC. In addition, Dr. Fowler serves as an Adjunct Professor, Emory University Rollins School of Public Health and Presidents Professor of Biomedical Sciences, Center for Alaska Native Health Research (CANHR) at the University of Alaska- Fairbanks. Dr. Fowler, is an internationally recognized expert on the toxicology of metals and has served on a number of State, National and International Committees in his areas of expertise. These include the Maryland Governor’s Council on Toxic Substances (Chair), various National Academy of Sciences / National Research Council Committees, including the 1993 landmark NAS/NRC Report on “Measuring Lead Exposure in Infants Children and Other Sensitive Populations” for which he served as the Committee Chair. He has also served on a number of review committees of the National Institutes of Health, the USEPA Science Advisory Board and the Fulbright Scholarship review committee for Scandinavia (Chair, 2000-2001). In 2016, he became an Inaugural Member of the Fulbright 1946 Society and in 2018 became a member of the Fulbright Association Board of Directors. He has also served as a temporary advisor to the World Health Organization (WHO) and on working groups of the International Agency for Research Against Cancer (IARC) for a number of toxicology and risk assessment issues. He is presently appointed as a member of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for the period 2016-2020. Dr. Fowler has been honored as a Fellow of the Japanese Society for the Promotion of Science (JSPS), a Fulbright Scholar and Swedish Medical Research Council Visiting Professor at the Karolinska Institute, Stockholm, Sweden and elected as a Fellow of the Academy of Toxicological Sciences. His more recent awards include a CDC/ATSDR, Honor Award for Excellence in Leadership Award 2010, The US Pharmacopea (USP) Toxicology Committee 2010-2015 and the USP Elemental Impurities Panel which received the 2014 U.S. Pharmacopea Award for an Innovative Response to Public Health Challenges (Group Award). He is currently appointed to the USP Nanotechnology Subcommittee 2015-. Dr. Fowler was previously elected to the Council of the Society of Toxicology (2005-2007), the Board of Directors of the Academy of Toxicological Sciences (2006-2009), and more recently, to the Council of the Society for Risk Analysis (2014-2017). He is the Federal Legislative and National Active and Retired Federal Employees Association and (NARFE)-PAC Chair for the Rockville Maryland Chapter of NARFE and is currently Chair of the Federal Legislative Committee for the Maryland NARFE Federation. Dr. Fowler is the Past- President of the Rotary Club of North Bethesda, Maryland (2016-2017) and was selected as Rotarian of the Year in 2015 for his work in developing a taxi-based program to help persons with disabilities gain independence via reliable transportation to work. Dr. Fowler is the author of over 260 research papers and book chapters dealing with molecular mechanisms of metal toxicity, molecular biomarkers for early detection of metal-induced cell injury and application of computational toxicology for risk assessment. He has been the editor, co-editor or author of 10 books or monographs on metal toxicology and mechanisms of chemical – induced cell injury, molecular biomarkers and risk assessment and computational toxicology. Dr. Fowler is currently focused on the global problem of electronic waste (e-waste) in developing countries. He serves on the editorial boards of a number of scientific journals in toxicology and is an Associate Editor of the journal Toxicology and Applied Pharmacology and a past Associate Editor of Environmental Health Perspectives (2007-2016).

Affiliations and Expertise

Private Consulting Toxicologist, Adjunct Professor, Emory University, Rollins School of Public Health, and Presidents Professor of Biomedical Research, University of Alaska - Fairbanks

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