Advances In Controlled Clinical Inhalation Studies
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Advances In Controlled Clinical Inhalation Studies
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Author : D.V. Bates
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Advances In Controlled Clinical Inhalation Studies written by D.V. Bates and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
Advances in Controlled Clinical Inhalation Studies represents scientific work presented at the 3rd International Inhalation Symposium held 1991 in Hannover, FRG. The symposium covered the new developments in this field of research. The main pollutants of interest were acid aerosols, fog, and indoor pollutants, while with regard to biological effects, an emphasis was placed on immunotoxicological and biochemical parameters. Tests on high risk groups were also considered. Initial chapters describe the outdoor environment as well as indoor air, measurement and quality - both at home and in the workplace. Besides methods for clinical inhalation and assessing personal exposure, new methodologies are particularly presented. Further chapters focus on the relevance of clinical data for regulatory decisions.
Pulmonary Drug Delivery
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Author : Ali Nokhodchi
language : en
Publisher: John Wiley & Sons
Release Date : 2015-08-03
Pulmonary Drug Delivery written by Ali Nokhodchi and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-03 with Science categories.
Drug therapy via inhalation route is at the cutting edge of modern drug delivery research. There has been significant progress on the understanding of drug therapy via inhalation products. However, there are still problems associated with their formulation design, including the interaction between the active pharmaceutical ingredient(s) (APIs), excipients and devices. This book seeks to cover some of the most pertinent issues and challenges of such formulation design associated with industrial production and desirable clinical outcome. The chapter topics have been selected with a view to integrating the factors that require consideration in the selection and design of device and formulation components which impact upon patient usability and clinical effectiveness. The challenges involved with the delivery of macromolecules by inhalation to both adult and pediatric patients are also covered. Written by leading international experts from both academia and industry, the book will help readers (formulation design scientists, researchers and post-graduate and specialized undergraduate students) develop a deep understanding of key aspects of inhalation formulations as well as detail ongoing challenges and advances associated with their development.
Controlled Human Inhalation Exposure Studies At Epa
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-04-10
Controlled Human Inhalation Exposure Studies At Epa written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-10 with Science categories.
The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.
Inhaled Medicines
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Author : Stavros Kassinos
language : en
Publisher: Academic Press
Release Date : 2021-02-05
Inhaled Medicines written by Stavros Kassinos and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-05 with Business & Economics categories.
Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ? Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ? Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ? Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ? Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues
Advances In Pulmonary Drug Delivery
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Author : Philip Chi Lip Kwok
language : en
Publisher: CRC Press
Release Date : 2016-12-19
Advances In Pulmonary Drug Delivery written by Philip Chi Lip Kwok and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-19 with Medical categories.
The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and parenteral administration. Pulmonary drug development is therefore a highly specialized area because of its many unique issues and challenges. Rapid progress is being made and offers novel solutions to existing treatment problems. Advances in Pulmonary Drug Delivery highlights the latest developments in this field.
Review Of The Environmental Protection Agency S Draft Iris Assessment Of Tetrachloroethylene
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2010-03-18
Review Of The Environmental Protection Agency S Draft Iris Assessment Of Tetrachloroethylene written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-03-18 with Nature categories.
Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.
Inhaled Pharmaceutical Product Development Perspectives
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Author : Anthony J. Hickey
language : en
Publisher: Elsevier
Release Date : 2017-11-23
Inhaled Pharmaceutical Product Development Perspectives written by Anthony J. Hickey and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-23 with Science categories.
Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel
Targeting Chronic Inflammatory Lung Diseases Using Advanced Drug Delivery Systems
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Author : Kamal Dua
language : en
Publisher: Academic Press
Release Date : 2020-08-04
Targeting Chronic Inflammatory Lung Diseases Using Advanced Drug Delivery Systems written by Kamal Dua and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-04 with Technology & Engineering categories.
Targeting Chronic Inflammatory Lung Diseases Using Advanced Drug Delivery Systems explores the development of novel therapeutics and diagnostics to improve pulmonary disease management, looking down to the nanoscale level for an efficient system of targeting and managing respiratory disease. The book examines numerous nanoparticle-based drug systems such as nanocrystals, dendrimers, polymeric micelles, protein-based, carbon nanotube, and liposomes that can offer advantages over traditional drug delivery systems. Starting with a brief introduction on different types of nanoparticles in respiratory disease conditions, the book then focuses on current trends in disease pathology that use different in vitro and in vivo models. The comprehensive resource is designed for those new to the field and to specialized scientists and researchers involved in pulmonary research and drug development. Explores recent perspectives and challenges regarding the management and diagnosis of chronic respiratory diseases Provides insights into how advanced drug delivery systems can be effectively formulated and delivered for the management of various pulmonary diseases Includes the most recent information on diagnostic methods and treatment strategies using controlled drug delivery systems (including nanotechnology)
Inhalation Studies
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Author : Robert F. Phalen
language : en
Publisher: CRC Press
Release Date : 2008-10-22
Inhalation Studies written by Robert F. Phalen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-10-22 with Medical categories.
This significantly updated and expanded new edition presents the scientific foundations of inhalation research essential to the design and conduct of toxicologic studies. It incorporates the major advances that have been made in the field, including recent advances in biology and the rapidly increasing global concerns and studies on particulate air pollution. The Second Edition was motivated by: new developments in the ultrafine particle health effects and concentrated aerosol research advances in understanding postnatal lung growth and the deposition and clearance of inhaled particles new techniques in toxicity testing the explosion of knowledge in the genetic and molecular realms the introduction of a large number of transgenic animal models updated ethical guidelines for animal testing the emergence of aerosol medicine the growing threat of aerosol-related terrorism increased appreciation of nonpulmonary effects of inhaled substances use of medical scanning techniques to study respiratory tract structure the introduction of new inhalation exposure systems the emergence of aerosol concentrators for use in air pollution studies
Controlled Pulmonary Drug Delivery
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Author : Hugh D.C. Smyth
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-06-24
Controlled Pulmonary Drug Delivery written by Hugh D.C. Smyth and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-24 with Medical categories.
The pace of new research and level of innovation repeatedly introduced into the field of drug delivery to the lung is surprising given its state of maturity since the introduction of the pressurized metered dose inhaler over a half a century ago. It is clear that our understanding of pulmonary drug delivery has now evolved to the point that inhalation aerosols can be controlled both spatially and temporally to optimize their biological effects. These abilities include controlling lung deposition, by adopting formulation strategies or device technologies, and controlling drug uptake and release through sophisticated particle technologies. The large number of contributions to the scientific literature and variety of excellent texts published in recent years is evidence for the continued interest in pulmonary drug delivery research. This reference text endeavors to bring together the fundamental theory and practice of controlled drug delivery to the airways that is unavailable elsewhere. Collating and synthesizing the material in this rapidly evolving field presented a challenge and ultimately a sense of achievement that is hopefully reflected in the content of the volume.