Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology discusses unique issues that may emerge during the development of new medicines and provides detailed insight on how to resolve them. This book employs a valuable translational strategy that integrates preclinical findings with the clinical resolution of those findings. It also 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 and raises them to the next level of importance by providing scientists with an indispensable resource to best address and resolve drug safety issues. Highlights advanced topics focused on safety pharmacology issues resulting during drug development and provides de-risking techniques and practical advice on how best to resolve these issuesCovers a broad selection of topics from 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 moreFocuses on the resolution of these issues in order to better address regulatory expectancies and develop safer and more effective drugs INDICE: 1. Introduction to Safety Pharmacology Issue Resolution in Drug Development 2. Application of Non-Animal Models to Issue Resolution 3. Value of Selecting Non-Traditional Species (not rat and not dog) for Issue Resolution Studies 4. Role of Age in Preclinical Studies in Safety Pharmacology 5. Importance of PK/PD modeling in Safety Pharmacology Issue Resolution 6. Problem solving on Issues of Sleep Disruption 7. Issue Resolution of Sleep Apnea and Respiratory Disorders 8. The Value of GI Evaluations in Designing a Successful Clinical Oncology Trial 9. Use of Peripheral Neuropathy Data to Design a Successful Clinical Oncology Trial 10. Use of High Frequency EEG (?50 HZ) in Problem-Solving 11. Issue Resolution of the Potential for Drug-Induced Self-Injurious Behavior 12. Approaches for Early Identification of Abuse Potential Liability 13. Utility of Progressive Ratio Testing in Abuse Liability Potential Assessment 14. Issue Resolution of Motor Deficits and Stereotypies 15. Biomarker Tools in Neurotoxicology Drug Development 16. The Role of Safety Pharmacology Studies in the Assessment of Drug-Induced Orthostatic Hypotension 17. Cardiovascular Issue Resolution 18. Application of Imaging in the Resolution of Safety Pharmacology Issues 19. Common Issues in Development of Large Molecules and Biologics 20. Future Needs in Issue Resolution of Problems that Arise in Drug Development

• ISBN: 978-0-12-812206-8
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 592
• Fecha Publicación: 01/08/2018
• Nº Volúmenes: 1
• Idioma: Inglés