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Chapter 1 - Introduction to Issue Resolution
Mary Jeanne Kallman
Pages 1-6 - Book chapterAbstract only
Chapter 2 - Selection of Nontraditional Species for Issue Resolution Studies
Judith W. Henck
Pages 7-40 - Book chapterAbstract only
Chapter 3 - The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments
Derek J. Leishman
Pages 41-59 - Book chapterAbstract only
Chapter 4 - Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events
Dennis J. Murphy
Pages 61-75 - 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 - Book chapterAbstract only
Chapter 6 - Sleep and Sleep Disruption
Joanne Stevens and Carrie Markgraf
Pages 103-129 - Book chapterAbstract only
Chapter 7 - Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management
Thomas J. Hudzik
Pages 131-141 - Book chapterAbstract only
Chapter 8 - Approaches for Early Identification of Abuse Potential Liability
Michael D.B. Swedberg
Pages 143-169 - Book chapterAbstract only
Chapter 9 - Issue Resolution of Motor Deficits and Stereotypies
David V. Gauvin
Pages 171-201 - Book chapterAbstract only
Chapter 10 - Issue Resolution Related to Convulsive Profiles
Marcus S. Delatte
Pages 203-223 - 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 - Book chapterAbstract only
Chapter 12 - Application of Imaging in the Resolution of Safety Pharmacology Issues
Eric I. Rossman
Pages 251-265 - Book chapterAbstract only
Chapter 13 - Cardiovascular Safety Pharmacology Issue Resolution
Annie Delaunois, Marie-Luce Rosseels and Jean-Pierre Valentin
Pages 267-285 - Book chapterAbstract only
Chapter 14 - Use of In Vitro Models in Drug Development and Issue Resolution
David O. Calligaro
Pages 287-302 - 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 - 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