Intravenous infusion is a necessary mode of delivery for many pharmaceuticals currently on the market or undergoing clinical trials. The technique of prolonged intravenous delivery in conscious, free-moving animal models has broadened the opportunity to study and evaluate the safety and efficacy of these therapeutic products. With contributions from an international selection of authors who are leaders in commercial infusion technology, Non-Clinical Vascular Infusion Technology, Volume II: The Techniques provides a current account of the techniques involved in all the major laboratory animal species for conducting successful vascular infusion studies with xenobiotics.
Following in the footsteps of the highly praised Handbook of Pre-Clinical Continuous Intravenous Infusion, this new volume covers both up-to-date procedures and equipment. It is organized by species, including all those commonly used in pre-clinical studies: rat, mouse, dog, minipig, large primate, and marmoset. There are also chapters on juvenile studies and reproductive toxicity studies. Each section addresses the selection of the best model, surgical and non-surgical best practices, practical techniques, equipment selection, and commonly encountered background pathologies.
Using a fresh approach, the authors identify best practices to be shared across the industry, and provide guidance on choices for the most acceptable methodologies from an animal welfare perspective. This volume, along with Volume I: The Science, provides a foundation of knowledge on infusion technology and its importance for safe clinical use of substances via this route of delivery.
- Emphasizes best practices in accordance with the 3Rs—reduction, refinement, and replacement of animal usage in laboratories
- Presents step-by-step procedures and practical tips covering a wide range of common animal models, augmented by the liberal use of illustrations
- Covers modern practices and procedures in accordance with up-to-date equipment development
Table of Contents
Jennifer Sheehan, Duncan Patten and Vasanthi Mowat
Hans van Wijk and Alice J M Fraser
John Cody Resendez and David Rehagen
Christine Copeman and Stephanie Clubb
Peter Glerup, Mikala Skydsgaard and Gitte Jeppesen
Teresa R. Gleason and George A. Parker
Dr. Sven Korte, Dr. Piotr Nowak, Dr. Jörg Luft and Dr. Birgit Niggemann
Owen Green is a toxicologist who has spent nearly 40 years in the preclinical toxicology industry within leading global CROs or as an independent consultant in toxicology to pharmaceutical and chemical sectors. Following his master’s degree in pharmacological biochemistry and Ph.D. studying chronic renal disease, he has spent many years working with and studying the practice of infusion technology in non-clinical toxicology programmes. He is one of the founders and current chairman of the Infusion Technology Organisation. This is an international group set up to share commercial and academic experiences with the technology in order to improve the techniques and scientific understanding for the benefit of the animal models involved and to improve the scientific quality of the data generated.
Guy Healing is an experienced regulatory toxicologist who has worked in pre-clinical pharmaceutical R&D for nearly 20 years, and prior to that in agrochemical R&D and for a global CRO. He obtained a BSc in biochemistry at Cardiff University and his Ph.D. investigating the role of iron and oxygen-derived free radicals in the pathogenesis of renal ischaemic damage while working for the Medical Research Council. Guy is a Fellow of the British Toxicology Society and has been editor of its newsletter as well as a member of the Executive Committee. He has published previously in the area of infusion technology, including the Handbook of Pre-clinical Continuous Intravenous Infusion in 2000.
"These are excellent reference books… a must read for anyone embarking on non-clinical infusion studies for the first time … I am sure will be found for years to come as well-used inhabitants of the working toxicologist’s bookshelf."
—Malcolm Blackwell, Sequani Ltd, UK in bst News
"Owen Green and Guy Healing have shown the importance of the 3Rs in infusion technology at international meetings and in producing this book."
—From the Foreword by Kathryn Chapman, Head of Innovation and Translation, the National Centre for the Replacement, Refinement and Reduction of Animals in Research
Praise for the First Edition, Handbook of Pre-clinical Continuous Intravenous Infusion
" ... an excellent buy for anyone involved in drug development, risk assessment or within drug licensing agencies and in academic research. ... This book represents a benchmark achievement for this technique ... it will become the standard for many years to come."
—British Toxicology Society Newsletter