Advances in Controlled Clinical Inhalation Studies PDF Download

Author: D.V. Bates
Publisher: Springer Science & Business Media
ISBN: 3642771769
Category : Medical
Languages : en
Pages : 423

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Book Description
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.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030945252X
Category : Science
Languages : en
Pages : 159

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Book Description
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.

Author: Stavros Kassinos
Publisher: Academic Press
ISBN: 0128149744
Category : Business & Economics
Languages : en
Pages : 438

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Book Description
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

Author:
Publisher:
ISBN:
Category : Pharmaceutical chemistry
Languages : en
Pages :

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Book Description
Covers the discovery development,regulation, manufacturing, and commercialization of drugs and dosage forms. Includes pharmaceuticals,pharmacokinetics, analytical chemistry, quality assurance, toxicology and the manufacturing process.

Author: Anthony J. Hickey
Publisher: Elsevier
ISBN: 0128123362
Category : Science
Languages : en
Pages : 112

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Book Description
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

Author: Philip Chi Lip Kwok
Publisher: CRC Press
ISBN: 131531195X
Category : Medical
Languages : en
Pages : 201

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Book Description
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.

Author: Hugh D.C. Smyth
Publisher: Springer Science & Business Media
ISBN: 1441997458
Category : Medical
Languages : en
Pages : 560

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Book Description
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.

Author: Hans Bisgaard
Publisher: CRC Press
ISBN: 0824741978
Category : Medical
Languages : en
Pages : 536

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Book Description
This book focuses on the aerosol treatment of lung diseases, recent improvements in the understanding of proper dosage, and major innovations in device technology applied to clinical practice. Examines the behavior of inspired spherical particles in the respiratory tract!Featuring over 1300 references, drawings, tables, and photographs.

Author: Robert F. Phalen
Publisher: CRC Press
ISBN: 9780849314001
Category : Medical
Languages : en
Pages : 288

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Book Description
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

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309453070
Category : Science
Languages : en
Pages : 487

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Book Description
Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.