Challenges in Nonhuman Primate Research in the 21st Century

 
 
Waxmann Verlag GmbH
  • 1. Auflage
  • |
  • erschienen am 1. Januar 2013
  • |
  • 180 Seiten
 
E-Book | PDF ohne DRM | Systemvoraussetzungen
978-3-8309-7839-8 (ISBN)
 
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.
  • Englisch
  • 1,58 MB
978-3-8309-7839-8 (9783830978398)
weitere Ausgaben werden ermittelt
1 - Contents [Seite 6]
2 - Preface [Seite 8]
3 - Regulatory Standards for the Approval of Biosimilar Products: A Global Review1 [Seite 10]
3.1 - Barbara Mounho-Zamora [Seite 10]
3.2 - Abstract [Seite 10]
3.3 - 1. Introduction [Seite 11]
3.4 - 2. History of the development of regulatory pathways for biosimilar products [Seite 14]
3.5 - 3. Biosimilar pathway in the European Union [Seite 16]
3.6 - 4. Biosimilar pathway in the United States [Seite 21]
3.7 - 5. Conclusions [Seite 30]
3.8 - 6. References [Seite 31]
4 - Biosimilars and Primate Toxicology - Practical Considerations and Challenges [Seite 36]
4.1 - Raymond Donninger [Seite 36]
4.2 - Abstract [Seite 36]
4.3 - 1. Introduction [Seite 36]
4.4 - 2. Regulations [Seite 37]
4.5 - 3. Biotherapeutic nonclinical safety development considerations [Seite 38]
4.6 - 4. Biosimilar nonclinical development considerations [Seite 39]
4.7 - 5. Primate toxicity studies [Seite 41]
4.8 - 5.4 Immunogenicity [Seite 44]
4.9 - 6. Other nonclinical studies [Seite 45]
4.10 - 7. Overall conclusions [Seite 45]
4.11 - 8. References [Seite 45]
5 - Social Housing for Nonhuman Primates: A Global Perspective [Seite 48]
5.1 - Jessica Couch, Heather Taylor, Kathryn Chapman [Seite 48]
5.2 - Abstract [Seite 48]
5.3 - 1. Introduction [Seite 48]
5.4 - 2. Examples of challenges in socialization of adult male NHPs [Seite 50]
5.5 - 3. Concerns and benefits of social housing for NHPs [Seite 52]
5.6 - 4. What is the current practice for care of adult NHPs? [Seite 53]
5.7 - 5. Potential challenges to success of social housing [Seite 54]
5.8 - 6. Other differences in socialization and enrichment practices between CRO sites [Seite 55]
5.9 - 7. Summary and conclusions [Seite 56]
5.10 - 8. Looking forward [Seite 57]
5.11 - 9. Acknowledgements [Seite 57]
5.12 - 10. References [Seite 58]
6 - Considerations for the Use of Nonhuman Primates in Nonclinical Safety Assessment [Seite 60]
6.1 - Jörg Bluemel [Seite 60]
6.2 - Abstract [Seite 60]
6.3 - 1. Introduction [Seite 60]
6.4 - 2. Nonhuman primates in toxicity testing [Seite 62]
6.5 - 3. Species selection for nonclinical safety studies [Seite 63]
6.6 - 4. Challenges in the refinement of nonclinical study designs [Seite 64]
6.7 - 5. Industry survey and retrospective analysis of NHP study designs [Seite 66]
6.8 - 6. Recommendations for refined / alternative study designs [Seite 67]
6.9 - 7. Conclusions and outlook [Seite 69]
6.10 - 8. References [Seite 70]
7 - Update on Nonhuman Primate Developmental and Reproductive Toxicity Evaluation [Seite 72]
7.1 - Gerhard F. Weinbauer [Seite 72]
7.2 - Abstract [Seite 72]
7.3 - 1. Introduction [Seite 73]
7.4 - 2. Fertility evaluation [Seite 73]
7.5 - 3. Pre- and postnatal development evaluation [Seite 77]
7.6 - 4. Implications of social housing for DART evaluation [Seite 82]
7.7 - 5. References [Seite 85]
8 - General and Specific Considerations Related to Reproductive and Developmental Toxicity [Seite 88]
8.1 - Annick Cauvin, PhD [Seite 88]
8.2 - Abstract [Seite 88]
8.3 - 1. Introduction [Seite 88]
8.4 - 2. Specificities of antibodies and choice of species for nonclinical evaluation [Seite 90]
8.5 - 3. Considerations for the design of non-clinical programs [Seite 92]
8.6 - 4. Specific considerations related to reproductive and developmental toxicity [Seite 95]
8.7 - 5. Reproductive and developmental assessment of Cimzia® [Seite 96]
8.8 - 6. Reproductive and developmental assessment of olokizumab [Seite 99]
8.9 - 7. Summary and conclusion [Seite 107]
8.10 - 8. References [Seite 108]
9 - Juvenile Animal Studies and Pediatric Investigation Plans [Seite 112]
9.1 - Mette Thomsen [Seite 112]
9.2 - Abstract [Seite 112]
9.3 - 1. Introduction - EU pediatric regulation [Seite 112]
9.4 - 2. The Pediatric Investigation Plan [Seite 113]
9.5 - 3. Waiver or PIP? [Seite 113]
9.6 - 4. Condition/indication for PIP [Seite 114]
9.7 - 5. When to produce a PIP? [Seite 115]
9.8 - 6. When to submit a PIP? [Seite 115]
9.9 - 7. PIPs after approval [Seite 116]
9.10 - 8. Modification of an agreed PIP [Seite 116]
9.11 - 9. Compliance check [Seite 117]
9.12 - 10. How to minimise the number of modifications of the PIP [Seite 117]
9.13 - 11. Nonclinical Studies to support pediatric trials: [Seite 118]
9.14 - 12. PIP - Purpose of nonclinical section [Seite 119]
9.15 - 13. What to include in the PIP [Seite 120]
9.16 - 14. PDCO nonclinical working group [Seite 121]
9.17 - 15. EMA's experience [Seite 122]
9.18 - 16. Case studies [Seite 124]
9.19 - 17. Increased number of juvenile animal studies? [Seite 125]
9.20 - 18. Conclusion [Seite 128]
9.21 - 19. References [Seite 129]
10 - Relevance and Importance of Nonhuman Primate Models in Regulatory Toxicology - Guideline Update for Biopharmaceuticals [Seite 132]
10.1 - Paul Baldrick [Seite 132]
10.2 - Abstract [Seite 132]
10.3 - 1. Introduction [Seite 132]
10.4 - 2. Primate use and biological activity/pharmacodynamics, safety pharmacology, exposure assessment [Seite 133]
10.5 - 3. Primate use and single dose toxicity, repeat dose toxicity and immunotoxicity [Seite 135]
10.6 - 4. Primate use and reproductive performance/development toxicity, genotoxicity, carcinogenicity and local tolerance [Seite 141]
10.7 - 5. Primate use and other areas of toxicological testing [Seite 143]
10.8 - 6. Overall conclusions [Seite 145]
10.9 - 7. References [Seite 146]
11 - Nonclinical Safety Assessment of Next Generation Biologicals: Nanobodies ® [Seite 150]
11.1 - Sandy Jacobs, Sandra De Boever, Marie-Paule Bouche, Maria Laura Sargentini- Maier, Hans Ulrichts, Josefi ne- Beate Holz, Judith Baumeister [Seite 150]
11.2 - Abstract [Seite 150]
11.3 - 1. Introduction: the Nanobody technology platform [Seite 151]
11.4 - 2. The unique properties of Nanobodies and their implications on safety and toxicity testing [Seite 152]
11.5 - 3. Case study 1: the anti-vWF Nanobody caplacizumab [Seite 155]
11.6 - 4. Case study 2: ALX-0141 [Seite 161]
11.7 - 5. Overall conclusions [Seite 166]
11.8 - 6. References [Seite 166]
11.9 - Acknowledgements [Seite 167]
12 - 19th Covance Primate Symposium - Closing Thoughts [Seite 168]
12.1 - Meredith Rocca [Seite 168]
12.2 - Biosimilars Development [Seite 168]
12.3 - Animal Use and Welfare [Seite 169]
12.4 - Nonhuman Primate DART and Juvenile Evaluation [Seite 170]
12.5 - Nanobodies [Seite 171]
12.6 - Safety Pharmacology [Seite 171]
12.7 - Take Action! [Seite 171]
13 - Speakers and Chairpersons [Seite 172]
14 - NINETEENTH PRIMATE SYMPOSIUM [Seite 174]
15 - Index [Seite 178]
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