Non-Clinical Vascular Infusion Technology, Volume I: The Science, 1st Edition (Paperback) book cover

Non-Clinical Vascular Infusion Technology, Volume I

The Science, 1st Edition

By Owen P. Green, Guy Healing

CRC Press

215 pages | 15 Color Illus. | 28 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 are brought together in one publication.

Non-Clinical Vascular Infusion Technology, Volume I: The Science covers the scientific principles behind the delivery systems, from both physical and physiological standpoints. The book 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. This volume, along with Volume II: The Techniques, provides a foundation of knowledge on infusion technology and its importance for safe clinical use of substances via this route of delivery.

Features

  • Identifies and shares best practices for non-clinical vascular infusion
  • Presents modern practices and procedures in line with up-to-date equipment development
  • Offers recommendations for in-life assessments in order to monitor the success or problems with the vascular infusion delivery
  • Makes comparisons with human data in many areas

Reviews

"Good science and good welfare go hand in hand. Innovative science and technology can be used to improve animal welfare. Equally, the 3Rs (replacement, refinement and reduction of animals in research) can provide fresh insight and novel approaches to advance science. By sharing data, knowledge and experience on the science behind infusion models and the refinement of the techniques used, there is the potential to have a significant impact on the 3Rs.

Owen Green and Guy Healing have shown the importance of the 3Rs in infusion technology at international meetings and in producing this book. The book will enhance uptake of the latest science behind vascular delivery systems to get better data and help influence decisions around the most appropriate model. It will also contribute to preventing repetition of method development and optimising experiments to answer specific scientific questions with the least impact on animals.

As in other areas of science, the field of infusion technology is constantly evolving. This edition of Non-Clinical Vascular Infusion Technology reviews current developments in the field that will support scientists in putting the 3Rs into practice."

—From the Foreword by Kathryn Chapman, Head of Innovation and Translation, the National Centre for the Replacement, Refinement and Reduction of Animals in Research

Table of Contents

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

About the Authors

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 masters 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