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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 d...
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| Corporate Authors: | |
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| Group Author: | ; ; |
| Published: |
Academic Press,
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| Publisher Address: | Amsterdam : |
| Publication Dates: |
2015. ©2015 |
| Literature type: | eBook |
| Language: | English |
| Subjects: | |
| Online Access: |
http://www.sciencedirect.com/science/book/9780124201729 |
| Summary: |
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. |
| Carrier Form: | 1 online resource |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9780124202160 0124202160 |
| Index Number: | HV5801 |
| CLC: | C913.8 |
| Contents: |
Front Cover; Nonclinical Assessment of Abuse Potential for New Pharmaceuticals; Copyright; CONTENTS; CONTRIBUTORS; FOREWORD; PREFACE; ACKNOWLEDGMENTS; Chapter 1 -- Nonclinical Assessment of Abuse Potential for New Pharmaceuticals in a Regulatory Space; 1. TERMINOLOGY; 2. ANIMAL MODELS OF ABUSE POTENTIAL; 3. REGULATION OF DRUGS OF ABUSE; 4. SCHEDULING; 5. SUMMARY; REFERENCES; Chapter 2 -- Neurochemistry of Abuse Liability Assessment and Primary Behavioral Correlates; 1. INTRODUCTION; 2. REWARD SYSTEM; REFERENCES; Chapter 3 -- Rat Self-Administration; 1. INTRODUCTION; 2. REGULATORY ISSUES 3. THE OPERANT CHAMBER SET UP4. THE TRAINING; 5. THE DRUG CONTINGENCIES; 6. THE TESTING; 7. DOSE-RESPONSE RELATIONSHIPS; 8. MAINTENANCE DRUG; 9. GENDER; 10. LIMITED VERSUS UNLIMITED ACCESS TO DRUG DURING TRAINING; 11. RESPONSE TOPOGRAPHY; 12. REINFORCING EFFICACY; 13. CONCLUSION; REFERENCES; Chapter 4 -- Nonhuman Primate Self-Administration in Assessments of Abuse Potential; 1. ASSESSMENT OF ABUSE POTENTIAL IN LABORATORY ANIMALS; 2. RATIONALE FOR USING NONHUMAN PRIMATES IN ASSESSMENTS OF ABUSE POTENTIAL; 3. STUDYING DRUG SELF-ADMINISTRATION IN NONHUMAN PRIMATES 4. STUDYING DRUG DEPENDENCE IN NONHUMAN PRIMATES5. CONCLUSIONS AND RECOMMENDATIONS; ACKNOWLEDGMENTS; REFERENCES; Chapter 5 -- Assessing Physical Dependence; 1. INTRODUCTION; 2. DEFINITIONS; 3. NEUROBIOLOGY OF WITHDRAWAL; 4. WITHDRAWAL: PRECIPITATED AND NONPRECIPITATED; 5. USE OF POSITIVE AND NEGATIVE CONTROLS IN THE WITHDRAWAL TEST; 6. ANIMAL MODEL OF NONPRECIPITATED WITHDRAWAL; 7. GENERAL CONSIDERATIONS; 8. GOOD LABORATORY PRACTICES; 9. REGULATORY GUIDANCE AND GLOBAL REGULATORY FRAMEWORK; 10. TIMELINES; 11. PHYSICAL DEPENDENCE TESTING OF LARGE MOLECULES 12. PHYSICAL DEPENDENCE TESTING IN HUMANS13. CONCLUSIONS; LIST OF ABBREVIATIONS; REFERENCES; Chapter 6 -- Drug Discrimination: Use in Preclinical Assessment of Abuse Liability; 1. FROM STATE DEPENDENCY TO DRUG DISCRIMINATION: A BRIEF HISTORY; 2. METHODOLOGY; 3. SOFTWARE; 4. TRAINING DRUGS; 5. DRUG DISCRIMINATION: TRAINING AND TESTING; 6. DATA INTERPRETATION: LEVELS OF GENERALIZATION; 7. THE DISCRIMINATIVE EFFECT; 8. TIME COURSE DETERMINATION; 9. PHARMACOKINETICS; 10. STRATEGIC PLACEMENT OF DRUG DISCRIMINATION IN THE ABUSE LIABILITY ASSESSMENT TOOLBOX 11. DRUG DISCOVERY AND DEVELOPMENT STRATEGIC USE OF DRUG DISCRIMINATIONREFERENCES; Chapter 7 -- Conditioned Place Preference as a Preclinical Model for Screening Pharmacotherapies for Drug Abuse; 1. INTRODUCTION; 2. BASIC PRINCIPLES OF CONDITIONED PLACE PREFERENCE; 3. APPLICATION OF CONDITIONED PLACE PREFERENCE TO MEDICATION DEVELOPMENT; 4. RECENT FINDINGS; 5. CONCLUSION; REFERENCES; Chapter 8 -- Utility of Intracranial Self-Stimulation in the Assessment of the Abuse Liability of New Pharmaceuticals; 1. INTRODUCTION |