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The nonhuman primate in nonclinical drug development and safety assessment

Author: Joerg Bluemel
Publisher: Amsterdam : Elsevier/Academic Press, ©2015.
Edition/Format:   Print book : EnglishView all editions and formats
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Document Type: Book
All Authors / Contributors: Joerg Bluemel
ISBN: 9780124171442 0124171443
OCLC Number: 895731131
Description: xviii, 684, [13] pages of plates : ill. ; 25 cm.
Contents: 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, [et al.]. --
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, [et al.] --
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.].
Responsibility: edited by Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard F. Weinbauer.
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"... useful to toxicologists and pharmaceutical scientists with limited experience in NHP-related work or toxicologists and pharmaceutical researchers seeking a comprehensive desktop reference. Read more...

 
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