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.
1. Chapter 1. Introduction to Issue Resolution - p. 1 2. Chapter 2. Selection of Nontraditional Species for Issue Resolution Studies - p. 7 3. Chapter 3. The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments - p. 41 4. Chapter 4. Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events - p. 61 5. Chapter 5. The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology - p. 77 6. Chapter 6. Sleep and Sleep Disruption - p. 103 7. Chapter 7. Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management - p. 131 8. Chapter 8. Approaches for Early Identification of Abuse Potential Liability - p. 143 9. Chapter 9. Issue Resolution of Motor Deficits and Stereotypies - p. 171 10. Chapter 10. Issue Resolution Related to Convulsive Profiles - p. 203 11. Chapter 11. Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments - p. 225 12. Chapter 12. Application of Imaging in the Resolution of Safety Pharmacology Issues - p. 251 13. Chapter 13. Cardiovascular Safety Pharmacology Issue Resolution - p. 267 14. Chapter 14. Use of In Vitro Models in Drug Development and Issue Resolution - p. 287 15. Chapter 15. Future Needs in Issue Resolution of Problems That Arise in Drug Development - p. 303 16. Index - p. 339
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.
1. Chapter 1. Introduction to Issue Resolution - p. 1 2. Chapter 2. Selection of Nontraditional Species for Issue Resolution Studies - p. 7 3. Chapter 3. The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments - p. 41 4. Chapter 4. Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events - p. 61 5. Chapter 5. The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology - p. 77 6. Chapter 6. Sleep and Sleep Disruption - p. 103 7. Chapter 7. Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management - p. 131 8. Chapter 8. Approaches for Early Identification of Abuse Potential Liability - p. 143 9. Chapter 9. Issue Resolution of Motor Deficits and Stereotypies - p. 171 10. Chapter 10. Issue Resolution Related to Convulsive Profiles - p. 203 11. Chapter 11. Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments - p. 225 12. Chapter 12. Application of Imaging in the Resolution of Safety Pharmacology Issues - p. 251 13. Chapter 13. Cardiovascular Safety Pharmacology Issue Resolution - p. 267 14. Chapter 14. Use of In Vitro Models in Drug Development and Issue Resolution - p. 287 15. Chapter 15. Future Needs in Issue Resolution of Problems That Arise in Drug Development - p. 303 16. Index - p. 339
