Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

ISBN-13: 9780124201729 / Angielski / Twarda / 2015 / 320 str.

Markgraf, Carrie Hudzik, Thomas Compton, David

Opis

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

Spis treści

Foreword Preface

1. Principles of Assessing Nonclinical Abuse Potential 
2. Neurochemistry of Drug Abuse
3. Regulatory Landscape for Abuse Liability 
4. Rodent Self-Administration Model
5. Primate Self-Administration Model
6. Physical Dependence Studies
7. Drug Discrimination Model
8. Conditioned Place Preference
9. Intra-cranial Self Stimulation
10. Clinical Evaluation of Abuse Potential for New Pharmaceuticals
11. Critical Decision Points in Abuse Potential Evaluation