Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

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 landscapeOffers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studiesIncludes real-life examples to illustrate how nonclinical data fit into the submission strategy INDICE: Foreword Preface Principles of Assessing Nonclinical Abuse Potential Neurochemistry of Drug AbuseRegulatory Landscape for Abuse Liability Rodent Self-Administration ModelPrimate Self-Administration ModelPhysical Dependence StudiesDrug Discrimination ModelConditioned Place PreferenceIntra-cranial Self StimulationClinical Evaluation of Abuse Potential for New PharmaceuticalsCritical Decision Points in Abuse Potential Evaluation

• ISBN: 978-0-12-420172-9
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 248
• Fecha Publicación: 01/08/2015
• Nº Volúmenes: 1
• Idioma: Inglés