
Advanced Issue Resolution in Safety Pharmacology
Description
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
Readership
Individuals interested in safety aspects of drug discovery and development including safety pharmacologists, nonclinical toxicologists, pharmacologists, clinicians, regulatory agency scientists, and academics (including graduate students and post-doctoral fellows) in medical sciences programs in these same areas
Table of Contents
1. Introduction to Issue Resolution
2. Selection of Nontraditional Species for Issue Resolution Studies
3. The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments
4. Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic Events
5. The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology
6. Sleep and Sleep Disruption
7. Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management
8. Approaches for Early Identification of Abuse Potential Liability
9. Issue Resolution of Motor Deficits and Stereotypies
10. Issue Resolution Related to Convulsive Profiles
11. Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments
12. Application of Imaging in the Resolution of Safety Pharmacology Issues
13. Cardiovascular Safety Pharmacology Issue Resolution
14. Use of In Vitro Models in Drug Development and Issue Resolution
15. Future Needs in Issue Resolution of Problems That Arise in Drug Development
Product details
- No. of pages: 360
- Language: English
- Copyright: © Academic Press 2018
- Published: September 5, 2018
- Imprint: Academic Press
- eBook ISBN: 9780128123348
- Hardcover ISBN: 9780128122068
About the Editors
Mary Kallman
Affiliations and Expertise
Michael Pugsley
Affiliations and Expertise
Ratings and Reviews
Latest reviews
(Total rating for all reviews)
KlausGerth Thu Dec 06 2018
Advanced Issue Resolution in Safety Pharmacology
Very informative book. Good overview and informative details