عنوان

The nonhuman primate in nonclinical drug development and safety assessment /

(Number (ISBN

0124171443

(Number (ISBN

9780124171442

Number

dltt

Title Proper

The nonhuman primate in nonclinical drug development and safety assessment /

General Material Designation

[Book]

First Statement of Responsibility

ed. by Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard F. Weinbauer

Place of Publication, Distribution, etc.

Amsterdam :

Name of Publisher, Distributor, etc.

Academic Press,

Date of Publication, Distribution, etc.

c2015

Specific Material Designation and Extent of Item

xviii, 684, [13] p. :

Other Physical Details

ill., plates ;

Dimensions

25 cm

Text of Note

Includes bibliographical references and index

Text of 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, [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. --

Text of 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, [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.]

0

8

Drug development-- Animal models

Primates as laboratory animals

Toxicity testing-- Animal models

Animals, Laboratory

Pharmaceutical Preparations

Primates

Toxicity testing

Bluemel, Joerg

Korte, Sven

Schenck, Emanuel

Weinbauer, Gerhard F

Date of Transaction

20150423021519.0

Electronic name

[Book]

Y