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Challenges in Nonhuman Primate Research in the 21st Century

:	Gerhard F. Weinbauer, Friedhelm Vogel
:	Challenges in Nonhuman Primate Research in the 21st Century
:	Waxmann Verlag GmbH
:	9783830978398
:	1
:	CHF 32.50
:

:	Medizin
:	English

:	180
:	kein Kopierschutz/DRM
:	PC/MAC/eReader/Tablet
:	PDF

In continuation of the Covance Primate Symposium Series, the 19th Covance Primate Symposium took place in Münster on 23rd& 24th of May 2012. Altogether, 70 participants representing 43 organisations, gathered for this symposium.
The 2012 Primate Symposium focussed on ?Challenges in Nonhuman Primate Research in the 21st Century?. The broad participation and the lively discussions during the symposium underlined the timeliness and importance of this topic. Expert speakers covered four major topics, i.e. biosimilars development: regulatory implications, key considerations and next steps, optimizing nonhuman primate use in nonclinical safety assessment, trends in nonhuman primate developmental& reproductive toxicology (DART) and juvenile toxicity evaluation, and relevance and importance of nonhuman primate models in regulatory toxicology. The development of biosimilar has taken up speed considerably and meanwhile needs to be considered a significant factor of potential drug development, yet there are still some uncertainties und guidelines are under development. With the increased focus on biopharmaceuticals and the associated increase for using nonhuman primates being the relevant animal model, it became necessary to optimize the use of this animal model, e.g. refine study designs and animals numbers but still execute meaningful preclinical studies. It appears that significant progress has been achieved in that context. In the area of nonhuman primate DART and juvenile toxicity evaluation, recent guideline changes had a major impact on species selection, and the experimental design plus the timing of these studies within the preclinical programmes. Finally, given the increasing regulations and justficiations of using nonhuman primates as experimental models. It is paramount to understand the essential and indispensable role that nonhuman primates can play in drug safety evaluation and medical drug development.

	Contents	6
	Preface	8
	Regulatory Standards for the Approval of Biosimilar Products: A Global Review1	10
	Barbara Mounho-Zamora	10
	Abstract	10
	1. Introduction	11
	2. History of the development of regulatory pathways for biosimilar products	14
	3. Biosimilar pathway in the European Union	16
	4. Biosimilar pathway in the United States	21
	5. Conclusions	30
	6. References	31
	Biosimilars and Primate Toxicology – Practical Considerations and Challenges	36
	Raymond Donninger	36
	Abstract	36
	1. Introduction	36
	2. Regulations	37
	3. Biotherapeutic nonclinical safety development considerations	38
	4. Biosimilar nonclinical development considerations	39
	5. Primate toxicity studies	41
	5.4 Immunogenicity	44
	6. Other nonclinical studies	45
	7. Overall conclusions	45
	8. References	45
	Social Housing for Nonhuman Primates: A Global Perspective	48
	Jessica Couch, Heather Taylor, Kathryn Chapman	48
	Abstract	48
	1. Introduction	48
	2. Examples of challenges in socialization of adult male NHPs	50
	3. Concerns and benefits of social housing for NHPs	52
	4. What is the current practice for care of adult NHPs?	53
	5. Potential challenges to success of social housing	54
	6. Other differences in socialization and enrichment practices between CRO sites	55
	7. Summary and conclusions	56
	8. Looking forward	57
	9. Acknowledgements	57
	10. References	58
	Considerations for the Use of Nonhuman Primates in Nonclinical Safety Assessment	60
	Jörg Bluemel	60
	Abstract	60
	1. Introduction	60
	2. Nonhuman primates in toxicity testing	62
	3. Species selection for nonclinical safety studies	63
	4. Challenges in the refinement of nonclinical study designs	64