Nonclinical Assessment of Abuse Potential for New Pharmaceuticals - Hardcover

David Compton

9780124201729: Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Hardcover

ISBN 10: 0124201725 ISBN 13: 9780124201729

Publisher: Academic Press Inc, 2015

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability.

Provides a consolidated overview of the complex regulatory landscape
Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies
Includes real-life examples to illustrate how nonclinical data fit into the submission strategy

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Review:

Incorporates regulatory guidelines for drugs with abuse potential, illustrates how to successfully conduct nonclinical studies, and provides material on clinical study methods to highlight all nonclinical, regulatory and clinical angles

About the Author:

Carrie is a native of Williamstown, MA. She received her BA from Middlebury College in Biology and Psychology, with an Honor’s Thesis investigating the role of the hippocampus in learned taste aversion. She received her MD, PhD from the University of Vermont, where her dissertation assessed the role of the central nucleus of the amygdala in cardiac arrhythmias. After graduation from UVM, she completed two post-doctoral fellowships at the University of Miami, FL: one in Psychology, where she also taught undergraduate classes in Introductory and advanced topics in psychology, and one in Neurology. It was during the post-doctoral fellowship in Neurology under Dr. Myron Ginsberg that she became involved in animal models of acute neurologic injury, creating some of the early behavioral outcome measures for assessing neurologic function in these models. Work in these models lead to a position at Marion Merrell Dow in Cincinnati OH, in the CNS Discovery group and after that to a position as Assistant Professor of Neurosurgery at the University of Texas-Houston Medical School. After nearly 10 years in the field of treatment of acute neurologic injury, Carrie started a new chapter of her career at Schering Plough as a Principal Scientist, then Senior Principal Scientist, setting up the company’s first CNS Safety Pharmacology lab, gaining skills in GLP regulations and serving in the roles of Study Director and Study Monitor for Safety Pharmacology and Toxicology studies. She also represented the department on Project Teams on various neuroscience programs. Now at Merck, as Senior Principal Scientist, Carrie is in Discovery Sciences Support and represents the department on Project Teams in varied therapeutic areas and serves on an internal group that assists programs with abuse liability issues.

Carrie has been a member the Society for Neuroscience since 1983, and has been a full member of SOT (Society of Toxicology) since 2001. She has also been a member of the Safety Pharmacology Society (SPS) since 2001, where she has served on a number of Committees, including the Program Committee and holding the position of Chair of the Academic Outreach Committee. She is currently serving on the Board of Directors of SPS as Secretary. At the annual meetings of these societies, Carrie has presented scientific posters, given symposia presentations and organized and served as the chair of symposia on drug abuse/liability. In 2010 she was Merck’s. representative to a PhRMA group responsible for industry’s response to the draft FDA guidance on Assessment of Abuse Potential of Drugs. Carrie has been a member of the CCALC (Cross-Company Abuse Liability Consortium) since its inception in 2006 and has served as Co-Lead of the PAL (Preclinical Abuse Liability) sub-group of CCALC since that time. She was a member of the CCALC organizing committees for the 2008 and 2015 FDA-Industry Dialogue sessions on abuse potential issues, and is also on the By-Laws committee to establish CCALC as a scientific non-profit organization. Carrie was a founding member of the non-profit New Jersey Brain Bee Association (NJBBA), a group dedicated to neuroscience educational outreach to area schools. The NJBBA also hosted an annual local competition in neuroscience for high school students. She continues her interest in educational outreach by speaking annually with student groups interested in careers in the pharmaceutical industry at Rutgers University and at Weill Cornell Medical School.

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