Markgraf / Hudzik / Compton | Nonclinical Assessment of Abuse Potential for New Pharmaceuticals | Buch | 978-0-12-420172-9 | sack.de

Buch, Englisch, 320 Seiten, Format (B × H): 189 mm x 248 mm, Gewicht: 269 g

Markgraf / Hudzik / Compton

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals


Erscheinungsjahr 2015
ISBN: 978-0-12-420172-9
Verlag: Elsevier Science

Buch, Englisch, 320 Seiten, Format (B × H): 189 mm x 248 mm, Gewicht: 269 g

ISBN: 978-0-12-420172-9
Verlag: Elsevier Science


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.

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Zielgruppe


Scientists in the pharmaceutical industry who conduct nonclinical studies (in Discovery and Nonclinical Safety departments); professionals who use the data in decision-making (Management, Regulatory and Project Managers); academics conducting research in these areas and clinicians in the pharmaceutical industry; Health Authority regulators

Weitere Infos & Material


Foreword Preface
- Principles of Assessing Nonclinical Abuse Potential

- Neurochemistry of Drug Abuse
- Regulatory Landscape for Abuse Liability

- Rodent Self-Administration Model
- Primate Self-Administration Model
- Physical Dependence Studies
- Drug Discrimination Model
- Conditioned Place Preference
- Intra-cranial Self Stimulation
- Clinical Evaluation of Abuse Potential for New Pharmaceuticals
- Critical Decision Points in Abuse Potential Evaluation


Hudzik, Thomas
Dr. Hudzik received his BA in experimental psychology from Rutgers College, and his MS and PhD from the University of New Orleans in Biological Psychology and Pharmacology in 1990. His Master's and Dissertation work focused upon how drug-drug interactions could elucidate mechanism of action of novel opioids. He had a highly productive fellowship at the University of Arkansas for Medical Sciences, where, under the guidance of Drs. McMillan and Wenger, he developed novel behavioral assays that addressed how drugs disrupt temporal perception, which was also useful in detecting antidepressant activity and neurotoxicity. Additionally, Dr Hudzik's postdoctoral work also addressed how drugs of abuse could interfere with working memory across multiple species such as primate, pigeon, rat and mouse. After his fellowship, he began his 22-year career in the pharmaceutical industry at Fisons Pharmaceuticals in Rochester, NY, which was later acquired by Astra AB, Sweden, then ultimately became AstraZeneca. He has worked to model and to identify novel targets on such diverse disease areas as substance use disorder, appetite suppression, epilepsy, stroke, neuroprotection, Alzheimer's, Parkinson's, anxiety, depression, schizophrenia, and bipolar disorder. During this time, he led research teams which delivered four candidate drugs into clinical development. He accepted a position at Abbott Labs in 2010 (now AbbVie), to develop an abuse liability strategy for the company, and leads a cross-functional team that addresses CNS safety concerns within projects. Dr Hudzik has authored more than 60 original research papers, and edited and contributed to 2 books. He is a member of the College on Problems of Drug Dependence, the List Committee of the World Anti-Doping agency, the Society for Neuroscience, the Behavioral Pharmacology Society, a reviewer of manuscripts for numerous journals, and is a very active participant in inter-company consortia supporting prediction of risk associated with abuse liability of novel drugs or the potential for psychiatric complications such as suicidal behavior, as well as two directed at discovery of early biomarkers for neurotoxicity. He enjoys teaching, and has served as an instructor for undergraduates, medical and nursing students, as well as presents on neuroscience topics to grammar school children. When not writing for science, Dr. Hudzik also enjoys writing fiction and poetry, running marathons, and brewing beer - usually not at the same time.

Markgraf, Carrie
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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