The nonhuman primate in nonclinical drug development and safety assessment

Weitere Verfasser: Bluemel, Joerg , [HerausgeberIn]
Ort/Verlag/Jahr: Amsterdam ; New York : Elsevier/AP, Academic Press is an imprint of Elsevier, [2015]
Umfang/Format: xviii, 684 pages : illustrations (some color) ; 25 cm
Schlagworte:
Primates as laboratory animals.
Drug development > Animal models.
Toxicity testing > Animal models.
Animals, Laboratory.
Primates.
Drug Discovery.
Models, Animal.
Pharmaceutical Preparations.
Toxicity Tests.
Online Zugang: Publisher description
Inhaltsangabe:
  • I. Genetics of nonhuman primate species commonly used in drug development: 1. Diversity and evolutionary history of macaques with special focus on Macaca mulatta and Macaca fascicularis / Christian Roos, Dietmar Zinner
  • 2. Evolutionary history and genetic variation of Macaca mulatta and Macaca fascicularis / Betsy Ferguson, David Glenn Smith
  • 3. Genetic variation of the major histocompatability complex in Macaca mulatta and Macaca fascicularis / Lutz Walter
  • 4. Genetic variations in the Macaca fascicularis genome related to biomedical research / Tobias Heckel [and others].
  • II. Comparative physiology of nonhuman primate species used in nonclinical safety assessment and drug development. 5. Basic physiology of Macaca fascicularis / Iris D. Bolton
  • 6. Basic physiology of Macaca mulatta / Anne D. Lewis, Kamm Prongay
  • 7. Basic physiology of Callithrix jacchus / Kerstin Mätz-Rensing, Sven Korte
  • 8. Comparative physiology, growth, and development / Wayne R. Buck
  • 9. Implications and limitations of reference values and historical data for the interpretation of nonhuman primate toxicology studies / Harry Yang, Laura Richman, Robert Hall.
  • III. Pathophysiology of nonhuman primate species used in nonclinical safety assessment and drug development: 10. Nonhuman primate diseases of relevance in drug development and their impact on the interpretation of study findings / Chandrassegar Saravanan, Vito G. Sasseville, Keith G. Mansfield
  • 11. Consequences and indicators of test article-related immune suppression in nonhuman primates / Jacintha M. Shenton, Kristin L. Henson, Marlon C. Rebelatto
  • 12. Toxicologic pathology and background lesions of nonhuman primates / Daniel J. Patrick, Marlon C. Rebelatto
  • 13. Nonhuman primate models of human disease / Jennifer A. Cann.
  • IV. The 3 Rs and animal welfare: 14. Opportunities for implementing the 3 Rs in drug development and safety assessment studies using nonhuman primates / Kathryn Chapman, [et al.]
  • 15. Training and selection of (mature) nonhuman primates for European housing / Wolfgang Müller, Susan Henwood.
  • V. The role of nonhuman primates in safety assessment/regulatory toxicology. 16. Nonclinical toxicology testing strategies and applicable international regulatory guidelines for using nonhuman primates in the development of biotherapeutics / Marque Todd, Michael W. Leach
  • 17. Alternatives to the use of nonhuman primates in regulatory toxicology / Georg Schmitt, Paul Barrow, Markus Stephan-Gueldner.
  • VI. Translational aspects for the use of nonhuman primates in drug development. 18. Pharmacokinetics of human therapeutics characterized in nonhuman primates / Chih-Ming L. Tseng, Raffaella Faggioni, Lorin K. Roskos.
  • VII. Nonhuman primate-specific aspects of standard toxicology studies. 19. Advantages and limitations of commonly used nonhuman primate species in research and development of biopharmaceuticals / Annick J. Cauvin, Christopher Peters, Frank Brennan
  • 20. Nonhuman primate health screening during acclimation/prestudy conditioning / William Oliver Iverson
  • 21. Study design considerations, technical procedural aspects, scheduling, and dosing sampling volumes / Werner Frings, Marc Niehoff, Sven Korte
  • 22. Functional assessments in nonhuman primate toxicology studies to support drug development / Jean-Pierre Valentin [and others]
  • 23. Considering the use of Callithrix jacchus / C. Marc Luetjens, [et al.].
  • VIII. Special toxicity testing with nonhuman primates. 25. Developmental and reproductive toxicity testing / Gerhard F. Weinbauer, [et al.]
  • 26. Juvenile animal studies and experience / Pauline L. Martin, Timothy P. Coogan
  • 27. Immunotoxicology testing of monoclonal antibodies in Macaca fascicularis: from manufacturing to preclinical studies / Marie-Soleil Piché, [et al.]
  • 28. Ophthalmological investigations in toxicity studies / Birgit Niggemann
  • 29. The use of nonhuman primates in cardiovascular safety assessment / Jonathan R. Heyen, Hugo M. Vargas
  • 30. Respiratory function measurements in nonhuman primates / Dennis J. Murphy
  • 31. Central nervous system assessment in nonhuman primates: behavioral assessment, neurological (electroencephalography, nerve conduction), abuse liability, and cognitive assessment / Mary Jeanne Kallman
  • 32. Skeletal assessments in the nonhuman primate / John L. Vahle, Yanfei L. Ma, David B. Burr
  • 33. Consideration for special administration techniques / Helen Palmer, Virginia Fisher.
  • IX. Future trends in primate toxicology. 34. Considerations regarding the future use of nonhuman primates to support the clinical development of biopharmaceuticals / Joy A. Cavagnaro, Beatriz Silva Lima
  • 35. Gaps and future challenges / Joerg Bluemel, [et al.].

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