http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Advanced issue resolution in safety pharmacology
Chapter 7. Self-Injurious Behavior in Clinical and Preclinical Populations: Description, Etiology, and Management; Introduction; Self-Injurious Behavior Overview; Self-Injurious Behavior in Nonhuman Experimental Subjects; Summary; Chapter 8. Approaches for Early Identification of Abuse Potential Liability; Introduction; Which Compounds Present an Issue for Preclinical Drug Abuse Liability Assessment?; An Integrated Approach for Assessment of Drug Abuse Liability; Examples of Abuse Liability Issue Resolution; Summary and Conclusions
Intro; Title page; Table of Contents; Copyright; List of Contributors; Chapter 1. Introduction to Issue Resolution; Chapter 2. Selection of Nontraditional Species for Issue Resolution Studies; Species Selection for Nonclinical Safety Pharmacology Studies; Species Considerations for Testing of Specific Organ Systems; Species Considerations for Testing of Biopharmaceuticals; Conclusion; Chapter 3. The Use of Modeling to Facilitate Decision-Making in Safety Pharmacology Assessments; What Are Models?; The Spectrum and Scale of Pharmacokinetic and Pharmacodynamic Models; Conclusions
Chapter 4. Issue Resolution of Drug-Induced Breathing Instability and the Occurrence of Apneic EventsIntroduction to Breathing Instability; Issues Associated With Breathing Instability; Resolution of the Drug-Induced Breathing Instability Issue; Chapter 5. The Impact of Drug-Induced Effects on the Gastrointestinal System: Challenges and Issue Resolution for Safety Pharmacology; Introduction; Common Gastrointestinal Effects in Nonclinical Safety Evaluations; Potential Impact of Gastrointestinal Effects on Core Safety Pharmacology Organ Systems; Mitigation Strategies
Conclusions and Future DirectionsFootnotes; Chapter 6. Sleep and Sleep Disruption; The Importance of Sleep; Measuring Sleep; Sleep Stages; Translatability of Electroencephalography in Sleep; Electroencephalography Frequencies; REM, Non-REM, and Wakefulness as a Translatable Biomarker; Changes in Sleep Patterns With Aging; Nondrug Disruption of Sleep; Drug-Induced Sleep Deprivation; Rapid Eye Movement Suppression; General Sleep Disturbances; Models of Sleep Disturbance; Circadian Rhythms; Using Genetic Models to Target Sleep Disruption and Normalize Sleep; Disruption of Sleep in Disease States
Chapter 9. Issue Resolution of Motor Deficits and StereotypiesRodents; Nonhuman Primates; Preclinical Screening; Conclusion; Chapter 10. Issue Resolution Related to Convulsive Profiles; Introduction; Determining the Biological Plausibility of a Drug Producing a Convulsion; Assessing the Risk of Convulsants; Managing the Risk of Drug-Induced Convulsions and Seizures; Using Nonclincal Data to Determine Safe Clinical Exposure Levels; Discussion; Chapter 11. Utility of Progressive Ratio Schedules of Reinforcement in Abuse Potential Assessments; Introduction; Study Design Considerations
edited by Mary Jeanne Kallman, Michael K. Pugsley.
Drug-Related Side Effects and Adverse Reactions
London, United Kingdom : Academic Press, an imprint of Elsevier, [2019]