1st Edition
by Mary Jeanne Kallman (Editor), Michael Pugsley (Editor)
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