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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Incorporates regulatory guidelines for drugs with abuse potential, illustrates how to successfully conduct nonclinical studies, and provides material on clinical study methods to highlight all nonclinical, regulatory and clinical angles

Carrie Markgraf (Edited by), Thomas Hudzik (Edited by), David Compton (Edited by)

9780124201729

Hardback, published 10 August 2015

320 pages, 25 illustrations
23.4 x 19 x 2.4 cm, 0.86 kg

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.

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

Subject Areas: Pharmacology [MMG], Public international law [LBB]

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