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Physiologically Based Pharmacokinetic (PBPK) Modeling

Methods and Applications in Toxicology and Risk Assessment

  • 1st Edition - May 20, 2020
  • Latest edition
  • Editors: Jeffrey W. Fisher, Jeffery M. Gearhart, Zhoumeng Lin
  • Language: English

Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and appli… Read more

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Description

Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and applications of PBPK modeling. Contributions from experts in PBPK modeling cover topics such as pharmacokinetic principles, classical physiological models, the application of physiological models for dose-response and risk assessment, the use of in vitro information, and in silico methods. With end-of-chapter exercises that allow readers to practice and learn the skills associated with PBPK modeling, dose-response, and its applications to safety and risk assessments, this book is a foundational resource that provides practical coverage of PBPK modeling for graduate students, academics, researchers, and more.

Key features

  • Provides end-of-chapter exercises to teach hands-on computational tools used in toxicology
  • Supplies computer code and explanations and includes examples of applied models used in regulatory toxicology and research
  • Authored by expert editors and contributors who are among the best PBPK modelers in the world

Readership

Faculty, researchers, post docs, and graduate students in the fields of toxicology, pharmacology, environmental health, epidemiology, risk assessment biostatistics, data analytics, and bioinformatics as well as working professionals, consultants, state and federal public health agencies, European health agencies (EU, trade groups)

Table of contents

Foreword
Melvin Andersen

Preface
Jeffrey W. Fisher, Zhoumeng Lin and Jeffery M. Gearhart

1. A history and recent efforts of selected physiologically based pharmacokinetic modeling topics
Zhoumeng Lin and Jeffrey W. Fisher

2. Introduction to classical pharmacokinetics
Shruti V. Kabadi and Zhoumeng Lin

3. Fundamentals of physiologically based pharmacokinetic modeling
Jeff Fisher, Xiaoxia Yang, Darshan Mehta, Conrad Housand and Zhoumeng Lin

4. Physiologically based pharmacokinetic modeling software
C.E. Hack, A.Y. Efremenko, S.N. Pendse, C.A. Ellison, A. Najjar, N. Hewitt, A. Schepky and H.J. Clewell III

5. Chemical absorption and writing code for portals of entry
Jeffrey W. Fisher, Jeffery M. Gearhart, Jerry L. Campbell Jr and Darshan Mehta

6. Physiologically based pharmacokinetic model: distribution processes
Christopher Ruark

7. Metabolism and physiologically based pharmacokinetic models
Jeffrey W. Fisher, Jerry L. Campbell Jr. and Zhoumeng Lin

8. Physiologically based pharmacokinetic model: excretion via urine, feces, and breath
Sami Haddad and Andy Nong

9. Sensitivity and Monte Carlo analysis techniques and their use in uncertainty, variability, and population analysis
Tammie R. Covington and Jeffery M. Gearhart

10. Physiologically based pharmacokinetic model calibration, evaluation, and performance assessment
Zhoumeng Lin, Yi-Hsien Cheng, Wei-Chun Chou and Miao Li

11. Examples of physiologically based pharmacokinetic modeling applied to risk assessment
Lisa M. Sweeney and Jeffery M. Gearhart

12. Physiologically based pharmacokinetic models to support modernized chemical safety assessment
Miyoung Yoon

Product details

  • Edition: 1
  • Latest edition
  • Published: May 21, 2020
  • Language: English

About the editors

JF

Jeffrey W. Fisher

Dr. Jeffrey Fisher is a research toxicologist with the U.S. Food and Drug Administration, National Center for Toxicological Research. He was formerly a Professor in the Department of Environmental Health Science, College of Public Health at the University of Georgia (UGA). He joined the University of Georgia in 2000 and served as Department Head of the Department of Environmental Health Sciences from 2000 to 2006 and Director of the Interdisciplinary Toxicology Program at UGA from 2006-2010. He spent most of his career at the Toxicology Laboratory, Wright Patterson AFB, where he was Principal Investigator and Senior Scientist in the Toxics Hazards Division and Technical Advisor for the Operational Toxicology Branch. Dr. Fisher has published over 170 papers on pharmacokinetics and PBPK modeling in laboratory animals and humans. He has served on several national panels and advisory boards for the DoD, ATSDR, USEPA and non-profit organizations. He was a U.S. delegate for the North Atlantic Treaty Organization. Dr. Fisher served on the International Life Sciences Institute Steering Committee, which evaluated chloroform and dichloroacetic acid using EPA-proposed Carcinogen Risk Guidelines. He is Past President of the Biological Modeling Specialty Section of the Society of Toxicology, reviewer for several toxicology journals, and was Co-Principal Investigator on a National Institutes of Health (NIH)-supported workshop on Mathematical Modeling at the University of Georgia in the fall of 2003. He was a member of the National Academy of Sciences subcommittee on Acute Exposure Guideline Levels (AEGLs) from 2004-2010 and Science Advisory Board for the US EPA (2007-2010). He is a fellow of the Academy of Toxicological Sciences and an associate editor for Toxicological Sciences. Dr. Fisher has a B.S. degree in biology from the University of Nebraska at Kearney, a M.S. degree in biology from Wright State University, and a Ph.D. in Zoology/Toxicology from Miami University.
Affiliations and expertise
Retired, Research Toxicologist, U.S. Food and Drug Administration, National Center for Toxicological Research, USA

JG

Jeffery M. Gearhart

Dr. Jeffery M. Gearhart is a Senior Toxicologist with the Henry M. Jackson Foundation for Military Medicine, working in the United States Air Force School of Aerospace Medicine, Aeromedical Department, Wright-Patterson AFB. Dr. Gearhart also is an adjunct professor in the Department of Pharmacology and Toxicology, at the Boonshoft School of Medicine, Wright State University, Dayton, Ohio. He has been a Diplomat of the American Board of Toxicology (DABT) since 1991 and been actively involved in the Society of Toxicology since 1981, a full member since 1990, having served as president and counselor for the Biological Modeling Specialty Section, and counselor for the Inhalation and Respiratory Specialty Section. Dr. Gearhart received his B.S. in Biology from the University of New Mexico and his M.S. while working at the Lovelace Inhalation Toxicology Research Institute, under Dr. Roger O. McClellan. He then studied inhalation and systemic toxicology at the Institute of Environmental Medicine at New York University, with Drs. Richard B. Schesinger and Dr. Morton Lippmann, receiving his Ph.D. in Environmental Health and Toxicology in 1987. Dr. Gearhart practiced corporate toxicology at The Proctor and Gamble Co after working with Drs. Kenneth Crump at the KS Crump Group and Dr. Harvey Clewell III consulting to a wide range of corporate clients in both the private and government sector.
Affiliations and expertise
Senior Toxicologist, Henry M. Jackson Foundation for Military Medicine, United States Air Force School of Aerospace Medicine, Aeromedical Department, Wright-Patterson AFB, USA

ZL

Zhoumeng Lin

Dr. Zhoumeng Lin is an Associate Professor in the Department of Environmental and Global Health at College of Public Health and Health Professions at the University of Florida. He is a member of the Center for Environmental and Human Toxicology (CEHT) and the Center for Pharmacometrics and Systems Pharmacology (CPSP). He received a B.Med. in Preventive Medicine from Southern Medical University in China in 2009 and a Ph.D. in Toxicology from the University of Georgia in 2013. He completed his postdoctoral training in Computational Toxicology in the Institute of Computational Comparative Medicine at Kansas State University in 2016. He was an Assistant Professor from 2016 to 2021 and then an Associate Professor from March to May 2021 at Kansas State University, prior to joining the University of Florida as an Associate Professor in May 2021. Dr. Lin’s research is focused on the development and application of computational technologies, especially physiologically based pharmacokinetic (PBPK) modeling, machine learning, and artificial intelligence approaches, to study nanomedicine, food safety, nanoparticle and chemical risk assessment. He is a co-author of more than 100 peer-reviewed manuscripts. He teaches two graduate level courses entitled “Physiologically Based Pharmacokinetic Modeling in Toxicology and Risk Assessment” and “Artificial Intelligence in Toxicology and Environmental Health”.

Affiliations and expertise
Associate Professor, Department of Environmental and Global Health, College of Public Health and Health Professions, University of Florida, Gainesville, USA

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