The nonhuman primate in nonclinical drug development and safety assessment / edited by Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard F. Weinbauer.

Format:

Book

Contributor:

Bluemel, Joerg, editor.

ScienceDirect (Online service)

Language:

English

Subjects (All):

Animal models.

Primates as laboratory animals.

Drug development--Animal models.

Drug development.

Toxicity testing--Animal models.

Toxicity testing.

Animals, Laboratory.

Primates.

Drug Discovery.

Models, Animal.

Pharmaceutical Preparations.

Toxicity Tests.

Medical Subjects:

Animals, Laboratory.

Primates.

Drug Discovery.

Models, Animal.

Pharmaceutical Preparations.

Toxicity Tests.

Physical Description:

1 online resource (xviii, 684 pages, 13 unnumbered pages of plates) : illustrations (some color), maps

Place of Publication:

Amsterdam : Elsevier/Academic Press, 2015.

[Place of publication not identified] : [publisher not identified], [2015]

System Details:

text file

Summary:

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment is a comprehensive reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. With important coverage of study planning and conduct, interspecies genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides the scientific and technical insights that will help readers safely and successfully use nonhuman primates in pharmaceutical toxicity testing. This complete and practical guide is intended for graduate students and new researchers as well as experienced practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates. Key Features, Presents comprehensive coverage of regulation-driven research in nonhuman primate drug development. Includes practical examples on techniques and methods that will help guide readers' daily practice. Addresses the ethics and the 3Rs (Replace, Refine and Reduce) in acknowledgments and appreciation of the important global focus on animal welfare. Book jacket.

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.

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.].

Notes:

Includes bibliographical references and index.

Electronic reproduction. Amsterdam Available via World Wide Web.

Description based on print version record.

Other Format:

Ebook version:

ISBN:

9780124171466

012417146X

Publisher Number:

99985134953

Access Restriction:

Restricted for use by site license.