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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment 1st Edition by Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard Weinbauer 9780124171442 0124171443

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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment 1st Edition Joerg Bluemel Digital Instant Download

Author(s): Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard Weinbauer
ISBN(s): 9780124171442, 0124171443
Edition: 1
File Details: PDF, 34.34 MB
Year: 2015
Language: english
SKU: EB-5031968 Category: Tags: , , ,

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment 1st Edition by Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard Weinbauer – Ebook PDF Instant Download/Delivery: 9780124171442, 0124171443

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Product details:

ISBN 10: 0124171443

ISBN 13: 9780124171442

Author: Joerg Bluemel, Sven Korte, Emanuel Schenck, Gerhard Weinbauer

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area.

  • Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more
  • Includes practical examples on techniques and methods to guide your daily practice
  • Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes

Table of contents:

Part I: Genetics of Nonhuman Primate Species Commonly Used in Drug Development

  • Chapter 1: Diversity and Evolutionary History of Macaques with Special Focus on Macaca mulatta and Macaca fascicularis

  • Chapter 2: Evolutionary History and Genetic Variation of Macaca mulatta and Macaca fascicularis

  • Chapter 3: Genetic Variation of the Major Histocompatibility Complex in Macaca mulatta and Macaca fascicularis

  • Chapter 4: Genetic Variations in the Macaca fascicularis Genome Related to Biomedical Research

Part II: Comparative Physiology of Nonhuman Primate Species Used in Nonclinical Safety Assessment and Drug Development

  • Chapter 5: Basic Physiology of Macaca fascicularis

  • Chapter 6: Basic Physiology of Macaca mulatta

  • Chapter 7: Basic Physiology of Callithrix jacchus

  • Chapter 8: Comparative Physiology, Growth, and Development

  • Chapter 9: Implications and Limitations of Reference Values and Historical Data for the Interpretation of Nonhuman Primate Toxicology Studies

Part III: Pathophysiology of Nonhuman Primate Species Used in Nonclinical Safety Assessment and Drug Development

  • Chapter 10: Nonhuman Primate Diseases of Relevance in Drug Development and their Impact on the Interpretation of Study Findings

  • Chapter 11: Consequences and Indicators of Test Article-Related Immune Suppression in Nonhuman Primates

  • Chapter 12: Toxicologic Pathology and Background Lesions of Nonhuman Primates

  • Chapter 13: Nonhuman Primate Models of Human Disease

Part IV: The 3 Rs and Animal Welfare

  • Chapter 14: Opportunities for Implementing the 3 Rs in Drug Development and Safety Assessment Studies Using Nonhuman Primates

  • Chapter 15: Training and Selection of (Mature) Nonhuman Primates for European Housing

Part V: The Role of Nonhuman Primates in Safety Assessment/Regulatory Toxicology

  • Chapter 16: Nonclinical Toxicology Testing Strategies and Applicable International Regulatory Guidelines for Using Nonhuman Primates in the Development of Biotherapeutics

  • Chapter 17: Alternatives to the Use of Nonhuman Primates in Regulatory Toxicology

Part VI: Translational Aspects for the Use of Nonhuman Primates in Drug Development

  • Chapter 18: Pharmacokinetics of Human Therapeutics Characterized in Nonhuman Primates

Part VII: Nonhuman Primate-specific Aspects of Standard Toxicology Studies

  • Chapter 19: Advantages and Limitations of Commonly Used Nonhuman Primate Species in Research and Development of Biopharmaceuticals

  • Chapter 20: Nonhuman Primate Health Screening During Acclimation/Prestudy Conditioning

  • Chapter 21: Study Design Considerations, Technical Procedural Aspects, Scheduling, and Dosing Sampling Volumes

  • Chapter 22: Functional Assessments in Nonhuman Primate Toxicology Studies to Support Drug Development

  • Chapter 23: Considering the Use of Callithrix jacchus

  • Chapter 24: Considerations on Immunogenicity

Part VIII: Special Toxicity Testing with Nonhuman Primates

  • Chapter 25: Developmental and Reproductive Toxicity Testing

  • Chapter 26: Juvenile Animal Studies and Experience

  • Chapter 27: Immunotoxicology Testing of Monoclonal Antibodies in Macaca fascicularis: From Manufacturing to Preclinical Studies

  • Chapter 28: Ophthalmological Investigations in Toxicity Studies

  • Chapter 29: The Use of Nonhuman Primates in Cardiovascular Safety Assessment

  • Chapter 30: Respiratory Function Measurements in Nonhuman Primates

  • Chapter 31: Central Nervous System Assessment in Nonhuman Primates

  • Chapter 32: Skeletal Assessments in the Nonhuman Primate

  • Chapter 33: Considerations for Special Administration Techniques

Part IX: Future Trends in Primate Toxicology

  • Chapter 34: Considerations Regarding the Future Use of Nonhuman Primates to Support the Clinical Development of Biopharmaceuticals

  • Chapter 35: Gaps and Future Challenges

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Tags: Joerg Bluemel, Sven Korte, Emanuel Schenck, Nonhuman