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.
- 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
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Techn.
ISBN-13
978-0-12-812334-8 (9780128123348)
Schweitzer Klassifikation
1. Introduction to Issue Resolution2. Selection of Nontraditional Species for Issue Resolution Studies3. The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments4. Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events5. The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology6. Sleep and Sleep Disruption7. Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management8. Approaches for Early Identification of Abuse Potential Liability9. Issue Resolution of Motor Deficits and Stereotypies10. Issue Resolution Related to Convulsive Profiles11. Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments12. Application of Imaging in the Resolution of Safety Pharmacology Issues13. Cardiovascular Safety Pharmacology Issue Resolution14. Use of In Vitro Models in Drug Development and Issue Resolution15. Future Needs in Issue Resolution of Problems That Arise in Drug Development