Bluemel / Korte / Schenck The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

1. Auflage 2015
ISBN: 978-0-12-417146-6
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 716 Seiten

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

Autoren/Hrsg.

Bluemel, Joerg

Korte, Sven

Schenck, Emanuel

Weinbauer, Gerhard

Leseproben

Contributors
Paul Barrow     F. Hoffmann-La Roche Ltd., Basel, Switzerland Kathryn Bayne     AAALAC International, Frederick, MD, USA Joerg Bluemel     MedImmune, Gaithersburg, MD, USA Frank Brennan     UCB Pharma, New Medicines, Non-Clinical Development, Slough, UK Iris D. Bolton     University of Texas Medical Branch, Galveston, TX, USA Christopher J. Bowman     Pfizer Inc., Groton, CT, USA Wayne R. Buck     AbbVie, Inc., North Chicago, IL, USA Leigh Ann Burns-Naas     Gilead Sciences, Inc., Foster City, CA, USA David B. Burr     Lilly Research Laboratories, Indianapolis, IN, USA Jennifer A. Cann     MedImmune, Gaithersburg, MD, USA Annick J. Cauvin     UCB Biopharma, New Medicine, Non-Clinical Development, Braine L’Alleud, Belgium Joy A. Cavagnaro     Access BIO, Boyce, VA, USA Ulrich Certa     F. Hoffmann–La Roche Ltd, Pharma Research & Early Development, Basel, Switzerland Kathryn Chapman     National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, United Kingdom Gary J. Chellman     Charles River Laboratories, Reno, NV, USA Timothy P. Coogan     Janssen Research and Development, LLC, Spring House, PA, USA Jessica Couch     Genentech, South San Francisco, CA, USA Lolke de Haan     Medimmune, Cambridge, United Kingdom Thierry Decelle     Sanofi Pasteur, Marcy L’Etoile, France Annie Delaunois     Non-Clinical Development, UCB Biopharma SPRL, Braine-l’Alleud, Belgium Raffaella Faggioni     Clinical Pharmacology & DMPK, MedImmune LLC, Mountain View, CA, USA Betsy Ferguson     Oregon Health & Sciences University and Oregon National Primate Research Center, Beaverton, OR, USA John Finch     Charles River Laboratories, Edinburgh, United Kingdom Virginia Fisher     Huntingdon Life Sciences Ltd, Huntingdon, United Kingdom Werner Frings     Chugai Pharmaceutical Co., Ltd., Gotemba, Japan Thomas Gelzleichter     Genentech, South San Francisco, CA, USA Andreas Gschwind     Center for Integrative Genomics, University of Lausanne, Lausanne, Switzerland Robert Hall     Covance Laboratories Inc., Madison, WI, USA Wendy G. Halpern     Genentech, South San Francisco, CA, USA Tobias Heckel     F. Hoffmann–La Roche Ltd, Pharma Research & Early Development, Basel, Switzerland Kristin L. Henson     Novartis Institutes for Biomedical Research, East Hanover, NJ, USA Susan Henwood     Covance, Madison, WI, USA Jonathan R. Heyen     Pfizer La Jolla, San Diego, CA, USA William Oliver Iverson     MedImmune, Gaithersburg, MD, USA Mary Jeanne Kallman     Covance Laboratories, Greenfield, IN, USA Joachim Kaspareit     Covance Laboratories, Münster, Germany Tina Koban     Huntingdon Life Sciences, Huntingdon, United Kingdom Sven Korte     Covance Laboratories GmbH, Münster, Germany Pierre Lainée     Animal Welfare and Research, Sanofi, Montpellier, France Michael W. Leach     Pfizer, Inc., Andover, MA, USA Lynne LeSauteur     Human Health Therapeutics, National Research Council, Montreal, QC, Canada Anne D. Lewis     Oregon National Primate Research Center, Oregon Health and Science University, Beaverton, OR, USA Beatriz Silva Lima     iMED.ULisboa, Universidade de Lisboa, Faculty of Pharmacy, Lisboa, Portugal Yanfei L. Ma     Lilly Research Laboratories, Indianapolis, IN, USA Keith G. Mansfield     Novartis Institutes for Biomedical Research, Inc., Cambridge, MA, USA C. Marc Luetjens     Covance Laboratories GmbH, Münster, Germany Pauline L. Martin     Janssen Research and Development, LLC, Spring House, PA, USA Kerstin Mätz-Rensing     German Primate Center, Göttingen, Germany Lars Fris Mikkelsen     Independent Barbara Mounho-Zamora     ToxStrategies, Inc., Bend, OR, USA Wolfgang Müller     Covance, Münster, Germany Dennis J. Murphy     GlaxoSmithKline Pharmaceuticals, King of Prussia, PA, USA Marc Niehoff     Covance Münster, Germany Birgit Niggemann     Covance Laboratories GmbH, Münster, Germany Helen Palmer     Huntingdon Life Sciences Ltd, Huntingdon, United Kingdom Daniel J. Patrick     MPI Research, Mattawan, MI, USA Christopher Peters     UCB Biopharma, New Medicine, Non-Clinical Development, Braine L’Alleud, Belgium Marie-Soleil Piché     Charles River Laboratories, Senneville, QC, Canada Mark Prescott     National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, United Kingdom Kamm Prongay     Oregon National Primate Research Center, Oregon Health and Science University, Beaverton, OR, USA Marlon C. Rebelatto     MedImmune, Biologics Safety Assessment, Gaithersburg, MD, USA Alexandre Reymond     Center for Integrative Genomics, University of Lausanne, Lausanne, Switzerland Laura Richman     Translational Sciences, MedImmune, Gaithersburg, MD, USA Christian Roos     Gene Bank of Primates and Primate Genetics Laboratory, German Primate Center, Leibniz Institute for Primate Research, Göttingen, Germany Lorin K. Roskos     Clinical Pharmacology & DMPK, MedImmune LLC, Mountain View, CA, USA Chandrassegar Saravanan     Novartis Institutes for Biomedical Research, Inc., Cambridge, MA, USA Vito G. Sasseville     Novartis Institutes for Biomedical Research, Inc., Cambridge, MA, USA Emanuel Schenck     MedImmune, Gaithersburg, MD, USA Georg Schmitt     F. Hoffmann-La Roche Ltd., Basel, Switzerland Jacintha M....