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Non-Clinical Vascular Infusion Technology, Two Volume Set : Science and Techniques /

"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 effica...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Green, Owen P. (Editor ), Healing, Guy (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Boca Raton, FL : CRC Press, 2014.
Edición:First edition.
Temas:
Acceso en línea:Texto completo

MARC

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245 1 0 |a Non-Clinical Vascular Infusion Technology, Two Volume Set :  |b Science and Techniques /  |c editors, Healing, Guy. 
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520 2 |a "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."--Provided by publisher. 
505 0 |a Cover; Volume I; Half Title; Title Page; Copyright Page; Contents; Foreword; Preface; Acknowledgements; Chapter 1 Body fluid dynamics; Introduction; Composition and units of measurement; Compartmentalisation and distribution; Movement between compartments/exchange; Body fluid homeostasis; Exchange of fluid between plasma and interstitial spaces; Zero balance; Fluid losses; Solute control -- Obligatory urinary water losses; Volume control -- Urinary free water; Fluid intake; Maintenance of body fluid balance; Summary; References; Chapter 2 Physico-chemical factors; Introduction; Osmolality. 
505 8 |a Co-author: Dean HattMeasurement of osmolality; Prediction of osmolality; The true effect of osmolality; Solutions containing solvents; Solutions containing high drug concentrations; Solutions containing glucose; Acid-base balance; Buffering; The bicarbonate-carbonic acid system; Proteins; Phosphates; Acidosis and alkalosis; Viscosity; Surface tension; Diffusion; Summary of infusion forces; References; Chapter 3 Vascular infusion dynamics; Essential physiology; Intravenous delivery rates and volumes; Literature review; Guidance for consideration; References. 
505 8 |a Chapter 4 Formulation considerationsIntroduction; Formulation selection strategy; Study design and species/strain; Dose; Endpoint, frequency, duration, and species; Properties of the compound; Solid form; Lipophilicity; Solubility and pKa; Salts; Stability; Hydrolysis; Oxidation; Photochemical degradation; Strategies for dealing with poor solubility; pH Adjustment; Buffers; Cosolvents; Complexing agents; Surfactants; Mixed micelles; Emulsions systems; Nanosuspensions; Top-down methods; Bottom-up methods; Formulation considerations for nanoparticles; Unwanted formulation effects. 
505 8 |a PharmacokineticsCosolvents; Cyclodextrins; Surfactants; Emulsion systems; Excipient toxicity; Tonicity modifiers; Cosolvents; Surfactants; Cyclodextrins; Strategies for dealing with injection site reactions and haemolysis; pH, buffer strength, osmolality and duration of infusion; Precipitation; Precipitation testing; Precipitation avoidance; Compound irritation; Reduced infusion time; Altering the ionisation state; Emulsions, surfactants and complexing agents; Choice of vein; Haemolysis; Strategies for dealing with poor stability; Removal of water; Additives; Sterility; Conclusion; References. 
505 8 |a Chapter 5 Prestudy analytical assessments: Equipment compatibilityIntroduction; Saline precipitation test; Stability of the formulation with the formulation storage vessel; Compatibility; Choice of material; References; Haemocompatibility; Introduction; Objectives; Methods of assessing haemocompatibility; Static method; Dynamic methods; Dynamic human forearm method; Dal Negro and Cristofori method; Test procedures; Compatibility with plasma; Discussion; Conclusion; References; Annex: Common excipients and vehicles; Index; Volume II; Half Title; Title Page; Copyright Page; Contents; Foreword. 
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650 0 |a Drug delivery systems. 
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