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Advanced Issue Resolution in Safety Pharmacology

Editat de Mary Jeanne Kallman, Michael Pugsley
en Limba Engleză Hardback – 7 sep 2018
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
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Specificații

ISBN-13: 9780128122068
ISBN-10: 0128122064
Pagini: 360
Dimensiuni: 191 x 235 mm
Greutate: 0.89 kg
Editura: ELSEVIER SCIENCE

Public țintă

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.

Cuprins

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