Non-Clinical Vascular Infusion Technology, Two Volume Set: Science and Techniques, 1st Edition (Hardback) book cover

Non-Clinical Vascular Infusion Technology, Two Volume Set

Science and Techniques, 1st Edition

Edited by Owen P. Green, Guy Healing

CRC Press

520 pages | 46 Color Illus. | 143 B/W Illus.

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Description

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. For the first time, the collective sciences involved in the understanding of this mode of drug delivery and the methodologies for carrying it out are brought together in a comprehensive work, Non-Clinical Vascular Infusion Technology, Two Volume Set: Science and Techniques.

Volume I: The Science covers the scientific principles behind the delivery systems, from both physical and physiological standpoints. It addresses body fluid dynamics, describes the scientific processes necessary to understand the various aspects of the physico-chemical issues relating to vascular infusion delivery, and discusses vascular infusion dynamics. It also considers all the essential elements of the preparation of a formulation intended for vascular delivery as well as assessment of compatibility of the formulation with the dosing apparatus.

Volume II: The Techniques builds upon the highly praised Handbook of Pre-Clinical Continuous Intravenous Infusion and provides a current account of the techniques and equipment involved in all the major laboratory animal species for conducting successful vascular infusion studies with xenobiotics. 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 two-volume set provides a foundation of knowledge on infusion technology and its importance for safe clinical use of substances via this route of delivery.

Reviews

"This book provides comprehensive, practice-oriented guidelines for scientists who design and perform studies with vascular drug delivery techniques. I highly recommend this book for both new and experienced scientists who plan to work with, or are already working with, vascular infusion techniques. Weighted numerical score: 96 - 4 stars."

—Ivan Laszlo Csanaky, MD, Ph.D, University of Kansas School of Medicine, Kansas City, USA from Doody's Book Reviews™

"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

Table of Contents

VOLUME I:

Body Fluid Dynamics

Introduction

Composition and units of measurement

Compartmentalization and Distribution

Movement between Compartments/Exchange

Body Fluid Homeostasis

Summary

References

Physico-Chemical Factors

Introduction

Osmolality

Acid-Base Balance

Viscosity

Surface Tension

Diffusion

Summary of Infusion Forces

References

Vascular Infusion Dynamics

Essential physiology

Intravenous Delivery Rates and Volumes

References

Formulation Considerations, Co-author: Kevin Sooben

Introduction

Formulation selection strategy

Study design and species/strain

The properties of the compound

Strategies for dealing with poor solubility

Unwanted formulation effects

Excipient toxicity

Strategies for dealing with injection site reactions and haemolysis

Strategies for dealing with poor stability

Sterility

Conclusion

References

Prestudy analytical assessments:

Equipment compatibility, Co-author: James Baker

Introduction

Stability of the formulation with the formulation storage vessel

Compatibility

Choice of material

References

Haemocompatibility, Co-author: Sophie Hill

Introduction

Objectives.

Methods of assessing haemocompatibility

Discussion

Conclusion

References

Annex: Common excipients and vehicles

VOLUME II:

Rat

Jennifer Sheehan, Duncan Patten and Vasanthi Mowat

Mouse

Hans van Wijk and Alice J M Fraser

Dog

John Cody Resendez and David Rehagen

Primate

Christine Copeman and Stephanie Clubb

Reproductive models

Minipig

Peter Glerup, Mikala Skydsgaard and Gitte Jeppesen

Juvenile animals

Teresa R. Gleason and George A. Parker

Marmoset

Dr. Sven Korte, Dr. Piotr Nowak, Dr. Jörg Luft and Dr. Birgit Niggemann

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MED089000
MEDICAL / Veterinary Medicine / General
MED096000
MEDICAL / Toxicology
MED106000
MEDICAL / Research