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140812s2015 ne a b 001 0 eng |
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|a 9780124171442
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|a 0124171443
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|a NLM
|b eng
|c NLM
|d BTCTA
|d WSU
|d YDXCP
|d UNL
|d CUD
|d OCLCQ
|d OCLCO
|d DLC
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|a The nonhuman primate in nonclinical drug development and safety assessment /
|c edited by Joerg Bluemel, Medimmune, Gaithersburg, MD, USA, Sven Korte, Covance Laboratories GMbH, Mümster, Germany, Emanuel Schenck, Medimmune, Gaithersburg, MD, USA, Gerhard F. Weinbauer, Covance Laboratories GMbH, Mümster, Germany.
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| 264 |
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|a Amsterdam ;
|a New York :
|b Elsevier/AP, Academic Press is an imprint of Elsevier,
|c [2015]
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|c ©2015
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| 300 |
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|a xviii, 684 pages :
|b illustrations (some color) ;
|c 25 cm
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a unmediated
|b n
|2 rdamedia
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| 338 |
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|a volume
|b nc
|2 rdacarrier
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| 504 |
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|a Includes bibliographical references and index.
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|a 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.
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|a 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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| 650 |
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|a Primates as laboratory animals.
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| 650 |
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|a Drug development
|x Animal models.
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| 650 |
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|a Toxicity testing
|x Animal models.
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| 650 |
1 |
2 |
|a Animals, Laboratory.
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| 650 |
1 |
2 |
|a Primates.
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| 650 |
2 |
2 |
|a Drug Discovery.
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| 650 |
2 |
2 |
|a Models, Animal.
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| 650 |
2 |
2 |
|a Pharmaceutical Preparations.
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| 650 |
2 |
2 |
|a Toxicity Tests.
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| 700 |
1 |
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|a Bluemel, Joerg
|9 292989
|e editor
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| 856 |
4 |
2 |
|3 Publisher description
|u http://www.loc.gov/catdir/enhancements/fy1606/2014948440-d.html
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