Nonclinical assessment of abuse potential for new pharmaceuticals / edited by Carrie G. Markgraf, Thomas J. Hudzik and David R. Compton.

Format:

Book

Contributor:

Markgraf, Carrie, editor.

Hudzik, Thomas, editor.

Compton, David, editor.

Language:

English

Subjects (All):

Drug abuse.

Drugs--Overdose.

Drugs.

Opioids--Overdose.

Opioids.

Physical Description:

1 online resource (321 p.)

Edition:

1st ed.

Place of Publication:

London, [England] ; San Diego, California : Academic Press, an imprint of Elsevier, 2015.

Language Note:

English

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. 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.

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

Notes:

Includes index.

Description based on online resource; title from PDF title page (ebrary, viewed July 23, 2015).

ISBN:

0-12-420216-0

0-12-420172-5

OCLC:

914434530