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
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
Dr. Kallman worked for Lilly Research Labs for 17 years as Group Leader for Safety Pharmacology and for Covance Laboratories, a large CRO, for 7 years as Director of Global Nonclinical Neuroscience. She retired from Covance in May of 2015 and she is currently managing a consulting business which provides input on CNS issue resolution and drug abuse liability strategies for drugs in development. She is past president of the Safety Pharmacology Society, past president for the Scientific Liaison Coalition of the Society of Toxicology and co-leader of the industry Cross Company Abuse Liability Consortium. She frequently publishes and presents on preclinical abuse liability issues and previously held National Institute of Drug Abuse RO1 grants on various abuse liability issues.
Dr. Pugsley currently works for Purdue Pharma LP as Director of Toxicology and PKDM. Prior to this he worked for Johnson & Johnson in the Drug Safety Sciences group conducting early discovery and IND-enabling Toxicology studies as well as Safety Pharmacology core battery studies for multiple therapeutic areas. Prior to this he was a Senior Principal Scientist at Forest Laboratories, Jersey City, NJ where he worked on a wide array of drugs that are currently used clinically such as Benicar for hypertension. Prior to his position at Forest, he worked at a biotechnology company called XOMA (US) LLC, in Berkeley, CA where he conducted in vivo and in vitro efficacy and safety pharmacology studies on a wide array of biologics for many therapeutic areas. He is currently the President of the Safety Pharmacology Society and has recently published a book entitled 'Principles of Safety Pharmacology'. He has also authored multiple reviews and published numerous scientific articles on safety pharmacology and serves on the editorial board of several pharmacology journals.