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Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Editat de Carrie Markgraf, Thomas Hudzik, David Compton
en Limba Engleză Hardback – 9 aug 2015
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
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Specificații

ISBN-13: 9780124201729
ISBN-10: 0124201725
Pagini: 320
Ilustrații: 25 illustrations
Dimensiuni: 191 x 235 x 23 mm
Greutate: 0.86 kg
Editura: ELSEVIER SCIENCE

Public țintă

Scientists in the pharmaceutical industry who conduct nonclinical studies (in Discovery and Nonclinical Safety departments); professionals who use the data in decision-making (Management, Regulatory and Project Managers); academics conducting research in these areas and clinicians in the pharmaceutical industry; Health Authority regulators

Cuprins

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