The nonhuman primate in nonclinical drug development and safety assessment (Record no. 11390)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05525cam a22002657i 4500 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| ISBN | 9780124171442 |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | SF407 |
| Item number | P7N65 |
| 245 04 - TITLE STATEMENT | |
| Title | The nonhuman primate in nonclinical drug development and safety assessment |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication | Amsterdam |
| Name of publisher | Elsevier |
| Year of publication | 2015 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Number of Pages | xviii, 684 p. |
| Other physical details | ill. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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.]. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Primates as laboratory animals. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Drug development |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Toxicity testing |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Animals, Laboratory. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Primates. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Drug Discovery. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Models, Animal. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Pharmaceutical Preparations. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Toxicity Tests. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bluemel, Joerg, |
| 856 42 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | http://www.loc.gov/catdir/enhancements/fy1606/2014948440-d.html |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Books |
| Withdrawn status | Lost status | Not for loan | Collection code | Home library | Current library | Shelving location | Date entered | Source of acquisition | Cost, normal purchase price | Full call number | Bar code | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shelf#19 | Directorate of Library Services | Directorate of Library Services | General Collection | 05/11/2021 | Book Aid International | 544000.00 | MED SF407.P7N65 | 000000130078 | Books |