Full Description
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.
Contents
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
