Cover for Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology

Book2018

Edited by:

Mary Jeanne Kallman and Michael K. Pugsley

Advanced Issue Resolution in Safety Pharmacology

Book2018

 

Cover for Advanced Issue Resolution in Safety Pharmacology

Edited by:

Mary Jeanne Kallman and Michael K. Pugsley

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Book description

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on ho ... read full description

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  2. Book chapterAbstract only

    Chapter 1 - Introduction to Issue Resolution

    Mary Jeanne Kallman

    Pages 1-6

  3. Book chapterAbstract only

    Chapter 2 - Selection of Nontraditional Species for Issue Resolution Studies

    Judith W. Henck

    Pages 7-40

  4. Book chapterAbstract only

    Chapter 3 - The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments

    Derek J. Leishman

    Pages 41-59

  5. Book chapterAbstract only

    Chapter 4 - Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events

    Dennis J. Murphy

    Pages 61-75

  6. Book chapterAbstract only

    Chapter 5 - The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology

    Marie-Luce Rosseels, Renaud Fleurance and Susan M.G. Goody

    Pages 77-101

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    Chapter 6 - Sleep and Sleep Disruption

    Joanne Stevens and Carrie Markgraf

    Pages 103-129

  8. Book chapterAbstract only

    Chapter 7 - Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management

    Thomas J. Hudzik

    Pages 131-141

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    Chapter 8 - Approaches for Early Identification of Abuse Potential Liability

    Michael D.B. Swedberg

    Pages 143-169

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    Chapter 9 - Issue Resolution of Motor Deficits and Stereotypies

    David V. Gauvin

    Pages 171-201

  11. Book chapterAbstract only

    Chapter 10 - Issue Resolution Related to Convulsive Profiles

    Marcus S. Delatte

    Pages 203-223

  12. Book chapterAbstract only

    Chapter 11 - Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments

    Jamie K. DaSilva, David B. Horton, ... Susan M.G. Goody

    Pages 225-250

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    Chapter 12 - Application of Imaging in the Resolution of Safety Pharmacology Issues

    Eric I. Rossman

    Pages 251-265

  14. Book chapterAbstract only

    Chapter 13 - Cardiovascular Safety Pharmacology Issue Resolution

    Annie Delaunois, Marie-Luce Rosseels and Jean-Pierre Valentin

    Pages 267-285

  15. Book chapterAbstract only

    Chapter 14 - Use of In Vitro Models in Drug Development and Issue Resolution

    David O. Calligaro

    Pages 287-302

  16. Book chapterAbstract only

    Chapter 15 - Future Needs in Issue Resolution of Problems That Arise in Drug Development

    Michael K. Pugsley, Matthew M. Abernathy, ... Michael J. Curtis

    Pages 303-338

  17. Book chapterNo access

    Index

    Pages 339-347

About the book

Description

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Key Features

  • Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice
  • Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more
  • Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs
  • Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice
  • Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more
  • Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs

Details

ISBN

978-0-12-812206-8

Language

English

Published

2018

Copyright

Copyright © 2018 Elsevier Inc. All rights reserved.

Imprint

Academic Press

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Editors

Mary Jeanne Kallman

Michael K. Pugsley