Release Date: 12 Mar 2015
Imprint: Academic Press
ISBN : 9780124171442

• Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more
• Includes practical examples on techniques and methods to guide your daily practice
• Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes
  
  
  
  Description
  The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area.
  
  
  Table of Contents
  Section I: Genetics of Nonhuman Primate Species Commonly Used in Drug Development
  1. Evolutionary History of Macaques and the Impact of Hybridization
  2. Evolutionary History and Genetic Variation in M. mulatta and M. fascicularis
  3. Major Histocompatability Complex Variation in the genome of M. mulatta and M. fascicularis
  4. Genetic variations in the Macaca fascicularis genome related to biomedical research
  
  Section II: Comparative Physiology of NHP Species Used in Nonclinical Safety Assessment and Drug Development
  5. Basic Physiology of the Cynomolgus Monkey
  6. Basic Physiology of the Rhesus Monkey
  7. Basic Physiology of the Marmoset
  8. Comparative Physiology, Organ System Maturation and Their Relation to Humans
  9. Implications and Limitations of Reference and Historical Values including Inter-Species Comparison for Safety Assessment
  
  Section III: Pathophysiology of NHP Species Used in Nonclinical Safety Assessment and Drug Development
  10. Primate Diseases of Relevance for Drug Development/Safety Assessment, Treatment Options and the Impact on Interpretation of Study Findings
  11. Consequences of Test Article-Induced Immune Suppression
  12. Toxicologic Pathology and Background Lesions of Common NHP Species
  13. The Nonhuman Primate as Animal Models of Human Diseases
  
  Section IV: Opportunities for implementing the 3Rs in drug development and safety assessment studies using nonhuman primates
  14. Opportunities for Implementing the 3Rs in Drug Development and Safety Assessment Studies Using Nonhuman Primates
  15. Training and Selection of (Mature) Monkeys for European Housing
  
  Section V: The Role of NHP in Safety Assessment/Regulatory Toxicology
  16. Regulatory Guidance, Strategy and Species Selection
  17. Alternatives to the Use of NHP in Regulatory Toxicology
  
  Section VI: Translational Aspects for the Use of NHP in Drug Development
  18. Pharmacokinetics of Human Therapeutics Characterized in Nonhuman Primates
  
  Section VII: NHP-Specific Aspects of Standard Toxicology Studies
  19. Advantages and Limitations of Commonly Used Primate Species
  20. NHP Animal Health During Acclimatization/Pre-Study Phases
  21. Study Design Considerations/Technical and Procedural Aspects and Schedule/Dosing and Sampling Volumes
  22. Integration of Safety Pharmacology Endpoints (CV, CNS, Respiration) in Standard Toxicology Studies
  23. Consideration on the Use of Marmoset
  24. Considerations on Immunogenicity
  
  Section VIII: Special Toxicity Testing with NHP
  25. Developmental and Reproductive Toxicology Testing
  26. Juvenile Animals Studies and Experience
  27. Design and Experience with Studies in Immunotoxicology
  28. Ophthalmological Assessments in NHP
  29. Assessment of Cardiovascular Function
  30. Assessment of Respiratory Function
  31. Neurological/Behavioral Assessment, Cognitive Tests and Abuse Liability
  32. Extended Assessment of Organ Function Using Bone Analysis
  33. Consideration for Special Administration Techniques
  
  Section IX: Future Trends in Primate Toxicology
  34. Vision and Critical Review about Futures of NHP use in Drug Development and Regulatory Trends
  35. Gaps and Future Challenges
  
  
  Joerg Bluemel
  Affiliations and Expertise
  PhD, ERT, Associate DIrector of Development Toxicology, Safety Assessment, Genentech, Inc., San Fransisco, CA