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Systems Pharmacology and Pharmacodynamics

  • Book
  • © 2016

Overview

Editors:
  1. Donald E. Mager

    1. Department of Pharmaceutical Sciences, University at Buffalo, SUNY, Buffalo, USA

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    You can also search for this editor in PubMed   Google Scholar

  2. Holly H.C. Kimko

    1. Global Clinical Pharmacology, Janssen Research and Development, LLC,, Spring House, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • First book that covers the expertise from systems biology and pharmacodynamics researchers in one place
  • Outlines how systems pharmacology should reduce the high attrition in the drug development pipeline
  • All case studies illustrate practical applications

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 23)

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Table of contents (20 chapters)

  1. Front Matter

    Pages i-xiii
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  2. Systems Modeling

    1. Front Matter

      Pages 1-1
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    2. Systems Pharmacology and Pharmacodynamics: An Introduction

      • Donald E. Mager, Holly H. C. Kimko
      Pages 3-14

    3. Role of Systems Modeling in Regulatory Drug Approval

      • Vikram Sinha, Shiew-Mei Huang, Darrell R. Abernethy, Yaning Wang, Ping Zhao, Issam Zineh
      Pages 15-25

    4. Quantitative Systems Pharmacology: Applications and Adoption in Drug Development

      • Saroja Ramanujan, Kapil Gadkar, Ananth Kadambi
      Pages 27-52

    5. Systems Pharmacology: An Overview

      • Marc R. Birtwistle, Jens Hansen, James M. Gallo, Sreeharish Muppirisetty, Peter Man-Un Ung, Ravi Iyengar et al.
      Pages 53-80

    6. Discrete Dynamic Modeling: A Network Approach for Systems Pharmacology

      • Steven Nathaniel Steinway, Rui-Sheng Wang, Reka Albert
      Pages 81-103

    7. Kinetic Models of Biochemical Signaling Networks

      • Mehdi Bouhaddou, Marc R. Birtwistle
      Pages 105-135

    8. Mechanistic Models of Physiological Control Systems

      • Michael C. K. Khoo, Wen-Hsin Hu, Patjanaporn Chalacheva
      Pages 137-158

  3. Pharmacodynamics

    1. Front Matter

      Pages 159-159
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    2. Foundations of Pharmacodynamic Systems Analysis

      • William J. Jusko
      Pages 161-175

    3. Direct, Indirect, and Signal Transduction Response Modeling

      • Wojciech Krzyzanski
      Pages 177-209

    4. Irreversible Pharmacodynamics

      • Alberto Russu, Italo Poggesi
      Pages 211-227

    5. Feedback Control Indirect Response Models

      • Yaping Zhang, David Z. D’Argenio
      Pages 229-253

    6. Nonlinear Mixed Effects Modeling in Systems Pharmacology

      • Peter L. Bonate, Amit Desai, Ahsan Rizwan, Zheng Lu, Stacey Tannenbaum
      Pages 255-276

    7. Detecting Pharmacokinetic and Pharmacodynamic Covariates from High-Dimensional Data

      • Jonathan Knights, Murali Ramanathan
      Pages 277-301

  4. Multi-scale Models of Drug Action

    1. Front Matter

      Pages 303-303
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    2. Multi-scale Modeling of Drug Action in the Nervous System

      • Hugo Geerts, Patrick Roberts, Athan Spiros, Robert Carr
      Pages 305-324

    3. Mechanistic Modeling of Inflammation

      • Jeremy D. Scheff, Kubra Kamisoglu, Ioannis P. Androulakis
      Pages 325-352

    4. Systems Pharmacology of Tyrosine Kinase Inhibitor-Associated Toxicities

      • Yoshiaki Kariya, Masashi Honma, Hiroshi Suzuki
      Pages 353-370
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Keywords

About this book

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

Editors and Affiliations

  • Department of Pharmaceutical Sciences, University at Buffalo, SUNY, Buffalo, USA

    Donald E. Mager

  • Global Clinical Pharmacology, Janssen Research and Development, LLC,, Spring House, USA

    Holly H.C. Kimko

About the editors

Donald E. Mager is a Professor of Pharmaceutical Sciences at the University at Buffalo, State University of New York. He also served as a Visiting Professor at the University Paris Descartes in January from 2007–2013 and 2016. He currently serves on the Clinical Pharmacology Advisory Committee to the FDA and the Editorial Advisory Boards of several journals. Dr. Mager also serves as an Associate or Consulting Editor at CPT:Pharmacometrics & Systems Pharmacology (CPT:PSP), Journal of Pharmacology & Experimental Therapeutics (JPET), and Pharmacology, Research & Perspectives (PRP). He is a former President of the International Society of Pharmacometrics and is a Fellow and member of the Board of Regents of the American College of Clinical Pharmacology. In addition, he is an expert member of the Board of Pharmaceutical Sciences at FIP and serves on the Scientific Advisory Board to Simcyp. His research focuses on identifying molecular and physiological factors that control the pharmacological properties of various drugs, with a focus on anti-cancer and immunomodulatory agents. He has contributed to 120+ peer-reviewed publications.

Holly H.C. Kimko-SA"> is a senior pharmacometrician in the Global Clinical Pharmacology department at Janssen Research & Development, LLC, Spring House, PA, and Adjunct Associate Professor in the Pharmacy School of Rutgers University, New Jersey. Dr. Kimko is a Janssen Research Fellow and American Association of Pharmaceutical Scientists Fellow. She championed the use of modeling and simulations in drug development at the Center for Drug Development Science at Georgetown University Medical School, Washington, DC in 1995–2002. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in pharmaceutical sciences from the University at Buffalo, State University of New York. She has published key papers on physiologically-based indirect response modeling and applications of clinical trial simulations and has edited two books on clinical trial simulations. Her research interests include strategic application of modeling and simulation tools in all aspects of drug development and post-approval life cycle management. Among her scientific endeavors is a specialty in pediatric drug development.


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