The nonhuman primate in nonclinical drug development and safety assessment / 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.

Other author Bluemel, Joerg.
Format Electronic
Publication InfoAmsterdam ; New York : Elsevier/AP, Academic Press is an imprint of Elsevier, [2015]
Descriptionxviii, 684 pages : illustrations (some color) ; 25 cm
Supplemental ContentFull text available from eBook - Pharmacology, Toxicology and Pharmaceutical Science 2015 [EBCPTPS15]
Subjects
Primates as laboratory animals.
Drug development--Animal models.
Toxicity testing--Animal models.
Animals, Laboratory.
Primates.
Drug Discovery.
Models, Animal.
Pharmaceutical Preparations.
Toxicity Tests.

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 [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.
Contents 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.].
Bibliography noteIncludes bibliographical references and index.
Access restrictionAvailable only to authorized users.
Technical detailsMode of access: World Wide Web
Genre/formElectronic books.
LCCN 2014948440
ISBN9780124171442
ISBN0124171443

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