Advanced Issue Resolution in Safety Pharmacology

Table of Contents

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

Authors

Mary Jeanne Kallman CEO, Kallman Preclinical Consulting. 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. Michael Pugsley Director of Toxicology and PKDM, Purdue Pharma LP. 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.