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Medical Regulatory Affairs

By Jack Wong,Raymond K. Y. Tong
  • Book ID : 1000440516
  • Publisher : CRC Press
  • Pages : 806
  • Genre : Medical
  • Reads : 177
  • eBook Format : Pdf, ePub, Mobi, Kindle
  • File Pdf: medical-regulatory-affairs.pdf

Book Summary:

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

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By David Mantus,Douglas J. Pisano
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Isbn : 1841849200
  • Pages : 400
  • Category : Medical
  • Reads : 198
  • File Pdf: fda-regulatory-affairs.pdf

Book Summary:

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Better Now

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Penguin
  • Isbn : 0735232601
  • Pages : 304
  • Category : Medical
  • Reads : 380
  • File Pdf: better-now.pdf

Book Summary:

Longlisted for British Columbia's National Award for Canadian Non-Fiction 2018 Dr. Danielle Martin sees the challenges in our health care system every day. As a family doctor and a hospital vice president, she observes how those deficiencies adversely affect patients. And as a health policy expert, she knows how to close those gaps. A passionate believer in the value of fairness that underpins the Canadian health care system, Dr. Martin is on a mission to improve medicare. In Better Now, she shows how bold fixes are both achievable and affordable. Her patients’ stories and her own family’s experiences illustrate the evidence she presents about what works best to improve health care for all. Better Now outlines “Six Big Ideas” to bolster Canada’s health care system. Each one is centred on a typical Canadian patient, making it clear how close to home these issues strike. · Ensure every Canadian has regular access to a family doctor or other primary care provider · Bring prescription drugs under medicare · Reduce unnecessary tests and interventions · Reorganize health care delivery to reduce wait times and improve quality · Implement a basic income guarantee to alleviate poverty, which is a major threat to health · Scale up successful local innovations to a national level Passionate, accessible, and authoritative, Dr. Martin is a fervent supporter of the best of medicare and a persuasive critic of what needs fixing.

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  • Format : Pdf, ePub, Mobi, Kindle
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  • Isbn : 1482843137
  • Pages : 414
  • Category : Self-Help
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  • File Pdf: selling-pharmaceuticals-a-love-affair.pdf

Book Summary:

This book is called A Love Affair basically for two reasons. The first is that I love medical representatives and wish to empower them to lead fruitful satisfying lives. I have myself worked for seventeen years as a medical representative. This book is the labour of Love and tribute for the medical representatives with whom I have been associated for thirty one years of my life. While rewriting the book for the second time I realised and was amazed by the similarity in the way that a sales persons job must be perused and in the way a young man woos his lady love to persuade her to marry him. In fact the similarities were so wide that the book demanded to be written as A Love Affair. This rewriting of the book made it suitable for all Sales People in addition to the medical representatives, hence the title. The second reason for calling it A Love Affair is the way that the book is written. All the aspects discussed here may be closely related to A Love Affair. Similarities occur that make the understanding of the sales process at once easy and interesting.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Isbn : 1498761313
  • Pages : 416
  • Category : Mathematics
  • Reads : 923
  • File Pdf: economic-evaluation-of-cancer-drugs.pdf

Book Summary:

Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, Economic Evaluation of Cancer Drugs using Clinical Trial and Real World Data is the first unified text that specifically addresses the economic evaluation of cancer drugs. The authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trials and building robust economic evaluation models that have a higher chance of reimbursement if truly cost-effective. They cover the use of real-world data using cancer registries and discuss how such data can support or complement clinical trials with limited follow up. Lessons learned from failed reimbursement attempts, factors predictive of successful reimbursement and the different payer requirements across major countries including US, Australia, Canada, UK, Germany, France and Italy are also discussed. The book includes many detailed practical examples, case studies and thought-provoking exercises for use in classroom and seminar discussions. Iftekhar Khan is a medical statistician and health economist and a lead statistician at Oxford Unviersity’s Center for Statistics in Medicine. Professor Khan is also a Senior Research Fellow in Health Economics at University of Warwick and is a Senior Statistical Assessor within the Licensing Division of the UK Medicine and Health Regulation Agency. Ralph Crott is a former professor in Pharmacoeconomics at the University of Montreal in Quebec, Canada and former head of the EORTC Health Economics Unit and former senior health economist at the Belgian HTA organization. Zahid Bashir has over twelve years experience working in the pharmaceutical industry in medical affairs and oncology drug development where he is involved in the design and execution of oncology clinical trials and development of reimbursement dossiers for HTA submission.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Atlantic Monthly Press
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  • Pages : 622
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  • File Pdf: code-blue.pdf

Book Summary:

This “searing and persuasive exposé of the American health care system” demonstrates the disastrous consequences of putting profit before people (Kirkus Reviews, starred review). In this timely and important book, Mike Magee, M.D., sends out a “Code Blue” —an urgent medical emergency—for the American medical industry itself. A former hospital administrator and Pfizer executive, he has spent years investigating the pillars of our health system: Big Pharma, insurance companies, hospitals, the American Medical Association, and anyone affiliated with them. Code Blue is a riveting, character-driven narrative that draws back the curtain on the giant industry that consumes one out of every five American dollars. Making clear for the first time the mechanisms, greed, and collusion by which our medical system was built over the last eight decades. He persuasively argues for a single-payer, multi-plan insurance arena of the kind enjoyed by every other major developed nation.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Isbn : 0429996772
  • Pages : 620
  • Category : Medical
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  • File Pdf: handbook-of-medical-device-regulatory-affairs-in-asia.pdf

Book Summary:

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : iUniverse
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  • File Pdf: nesiritide.pdf

Book Summary:

This remarkably insightful book gives true meaning to the apocryphal moan from the pharmaceutical CEO as he traveled home after an FDA slap down: Drug development aint for sissies. Peter Kowey, MD, author of LETHAL RHYTHM, DEADLY RHYTHM and THE EMPTY NET When Roger Mills, a medical school professor, made a late-career move from academic cardiology to the pharmaceutical industry, he had no idea what the next decade would bring. At the University of Florida in the late 1990s, he had been a clinical investigator in a phase 2 trial studying the dosing and efficacy of nesiritide, which Scios Inc. was attempting to bring to the market. He joined the company in 2005, and soon became its vice president for medical affairs. Nesiritide was the biotechnology companys only product in clinical development, and after a stunning turn of events at a Food and Drug Administration meeting in 1999, company president Dick Brewer had to use all his smarts to keep the company together and reverse its fortunes. Johnson & Johnson would eventually acquire the company in 2003 for $2.4 billion, but then found it would have to decide how to deal with safety concerns raised about the drug after two scientific publications claimed it could cause kidney failure and death. Get a revealing look at what it really takes to develop and introduce a drug to market and all the things that can go wrong in Nesiritide.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Isbn : 0128007907
  • Pages : 360
  • Category : Medical
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  • File Pdf: re-engineering-clinical-trials.pdf

Book Summary:

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Communities in Action

By National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Committee on Community-Based Solutions to Promote Health Equity in the United States
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : National Academies Press
  • Isbn : 0309452996
  • Pages : 582
  • Category : Medical
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  • File Pdf: communities-in-action.pdf

Book Summary:

In the United States, some populations suffer from far greater disparities in health than others. Those disparities are caused not only by fundamental differences in health status across segments of the population, but also because of inequities in factors that impact health status, so-called determinants of health. Only part of an individual's health status depends on his or her behavior and choice; community-wide problems like poverty, unemployment, poor education, inadequate housing, poor public transportation, interpersonal violence, and decaying neighborhoods also contribute to health inequities, as well as the historic and ongoing interplay of structures, policies, and norms that shape lives. When these factors are not optimal in a community, it does not mean they are intractable: such inequities can be mitigated by social policies that can shape health in powerful ways. Communities in Action: Pathways to Health Equity seeks to delineate the causes of and the solutions to health inequities in the United States. This report focuses on what communities can do to promote health equity, what actions are needed by the many and varied stakeholders that are part of communities or support them, as well as the root causes and structural barriers that need to be overcome.

Dictionary of Pharmaceutical Medicine

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Isbn : 3709140161
  • Pages : 179
  • Category : Medical
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  • File Pdf: dictionary-of-pharmaceutical-medicine.pdf

Book Summary:

This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.

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  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Isbn : 135171287X
  • Pages : 227
  • Category : Medical
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  • File Pdf: conceptualising-public-health.pdf

Book Summary:

In Germanic and Nordic languages, the term for ‘public health’ literally translates to ‘people’s health’, for example Volksgesundheit in German, folkhälsa in Swedish and kansanterveys in Finnish. Covering a period stretching from the late nineteenth century to the present day, this book discusses how understandings and meanings of public health have developed in their political and social context, identifying ruptures and redefinitions in its conceptualisation. It analyses the multifaceted and interactive rhetorical play through which key concepts have been used as political tools, on the one hand, and shaped the understanding and operating environment of public health, on the other. Focusing on the blurred boundaries between the social and the medico-scientific realms, from social hygiene to population policy, Conceptualising Public Health explores the sometimes contradictory and paradoxical normative aims associated with the promotion of public health. Providing examples from Northern Europe and the Nordic countries, whilst situating them in a larger European and international context, it addresses questions such as: How have public health concepts been used in government and associated administrative practices from the early twentieth century up to the present? How has health citizenship been constructed over time? How has the collective entity of ‘the people’ been associated with and reflected in public health concepts? Drawn from a range of disciplinary backgrounds, the authors collected here each examine a particular way of understanding public health and assess how key actors or phenomena have challenged, altered or confirmed past and present meanings of the concept. Conceptualising Public Health is of interest to students and scholars of health and welfare state development from diverse backgrounds, including public health, sociology of health and illness, and social policy as well as medical, conceptual and intellectual history.

The Identity of the History of Science and Medicine

By Andrew Cunningham
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Isbn : 1351219529
  • Pages : 284
  • Category : Science
  • Reads : 867
  • File Pdf: the-identity-of-the-history-of-science-and-medicine.pdf

Book Summary:

In these essays, Andrew Cunningham is concerned with issues of identity - what was the identity of topics, disciplines, arguments, diseases in the past, and whether they are identical with (more usually, how they are not identical with) topics, disciplines, arguments or diseases in the present. Historians usually tend to assume such continuous identities of present attitudes and activities with past ones, and rarely question them; the contention here is that this gives us a false image of the very things in the past that we went to look for.

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By Martin Torgoff
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Da Capo Press
  • Isbn : 0306824760
  • Pages : 448
  • Category : History
  • Reads : 619
  • File Pdf: bop-apocalypse.pdf

Book Summary:

!--[if gte mso 9] ![endif]-- The gripping story of the rise of early drug culture in America, from the author of the acclaimed Can't Find My Way Home With an intricate storyline that unites engaging characters and themes and reads like a novel, Bop Apocalypse details the rise of early drug culture in America by weaving together the disparate elements that formed this new and revolutionary segment of the American social fabric. Drawing upon his rich decades of writing experience, master storyteller Martin Torgoff connects the birth of jazz in New Orleans, the first drug laws, Louis Armstrong, Mezz Mezzrow, Harry Anslinger and the Federal Bureau of Narcotics, swing, Lester Young, Billie Holiday, the Savoy Ballroom, Reefer Madness, Charlie Parker, the birth of bebop, the rise of the Beat Generation, and the coming of heroin to Harlem. Aficionados of jazz, the Beats, counterculture, and drug history will all find much to enjoy here, with a cast of characters that includes vivid and memorable depictions of Billie Holiday, Miles Davis, John Coltrane, Jackie McLean, Allen Ginsberg, William S. Borroughs, Jack Kerouac, Herbert Huncke, Terry Southern, and countless others. Bop Apocalypse is also a living history that teaches us much about the conflicts and questions surrounding drugs today, casting many contemporary issues in a new light by connecting them back to the events of this transformative era. At a time when marijuana legalization is rapidly becoming a reality, it takes us back to the advent of marijuana prohibition, when the templates of modern drug law, policy, and culture were first established, along with the concomitant racial stereotypes. As a new opioid epidemic sweeps through white working- and middle-class communities, it brings us back to when heroin first arrived on the streets of Harlem in the 1940s. And as we debate and grapple with the gross racial disparities of mass incarceration, it puts into sharp and provocative focus the racism at the very roots of our drug war. Having spent a lifetime at the nexus of drugs and music, Torgoff reveals material never before disclosed and offers new insights, crafting and contextualizing Bop Apocalypse into a truly novel contribution to our understanding of jazz, race, literature, drug culture, and American social and cultural history.

The Trainings of the Psychoanalyst

By Annie Tardits
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Isbn : 0429922485
  • Pages : 176
  • Category : Psychology
  • Reads : 540
  • File Pdf: the-trainings-of-the-psychoanalyst.pdf

Book Summary:

If psychoanalysis, for Freud, was an impossible profession, what consequences would this have for psychoanalytic training? And if one's own personal analysis lay at the heart of psychoanalytic training, how could what one had learnt from this be transmitted, let alone taught? In this groundbreaking book, the aurhor explores the many attempts that analysts have made to think through the problems of psychoanalytic training. Moving from Freud and his first students through to Lacan and his invention of the 'pass', the author charts the changing conceptions of psychoanalytic training. With clarity and elegance, she shows how different ideas of what psychoanalysis is will have effects on how training is understood.If psychoanalysis involves each person's unique unravelling of the unconscious and of sexuality, what kind of training would be appropriate, or even possible?

Innovation in Clinical Trial Methodologies

By Peter Schueler
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Isbn : 0323860060
  • Pages : 202
  • Category : Medical
  • Reads : 757
  • File Pdf: innovation-in-clinical-trial-methodologies.pdf

Book Summary:

Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

On the Nature of Health

By L.Y Nordenfelt
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Isbn : 9401577684
  • Pages : 204
  • Category : Medical
  • Reads : 579
  • File Pdf: on-the-nature-of-health.pdf

Book Summary:

GENERAL INTRODUCTION This study of the concept of health is an attempt to combine central ideas in modern philosophy of medicine with certain results from analytical action theory. What emerges from the study is a concept of health based on an action-theoretic foundation. A person's health is characterized as his ability to achieve his vital goals. The general conception is not new. This study has been inspired by a number of scholars, both ancient and modern. The most important influences from the latter have been those of Georges Canguilhem, H. Tristram Engelhardt Jr. , Caroline Whitbeck and Ingmar Pörn. The novel aspect of this book consists of elaborations made to the general conception. First, the action-theoretic platform is analysed in some detail. The nature of the ability involved, as well as the conditions for having that ability, are specified. Second, the vital goals of man are given considerable attention. Some previous attempts to define such vital goals are analysed and criticized. A new characterization is proposed, in which the vital goals are conceptually linked to the notion of happiness. A person's vital goals are such states of affairs as are necessary and together sufficient for his minimal happiness. Third, a number of consequences of this con ception are observed and analysed. One issue which is particularly empha sized is that ofwhether the concept ofhealth is a theoretical or a normative concept.

When Experiments Travel

By Adriana Petryna
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Princeton University Press
  • Isbn : 1400830826
  • Pages : 272
  • Category : Social Science
  • Reads : 922
  • File Pdf: when-experiments-travel.pdf

Book Summary:

The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.

Transcultural Humanities in South Asia

By Waseem Anwar
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Isbn : 1000539156
  • Pages : 516
  • Category : Literary Criticism
  • Reads : 639
  • File Pdf: transcultural-humanities-in-south-asia.pdf

Book Summary:

This volume looks at the implications of transcultural humanities in South Asia, which is becoming a crucial area of research within literary and cultural studies. The volume also explores various complex critical dimensions of transculturation, its indeterminate periodisation, its temporal and spatial nonlinearity, its territoriality and intersectionality. Drawing on contributors from around the globe, the entries look at literature and poetics, theory and praxis, borders and nations, politics, Partition, gender and sexuality, the environment, representations in art and pedagogy and the transcultural classroom. Using key examples and case studies, the contributors look at current developments in transcultural and transnational standpoints and their possible educational outcomes. A broad and comprehensive collection, as it also speaks about the value of the humanities and the significance of South Asian contexts, Transcultural Humanities in South Asia will be of particular interest to those working on postcolonial studies, literary studies, Asian studies and more.

Tentacles Longer Than Night

By Eugene Thacker
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : John Hunt Publishing
  • Isbn : 1782798889
  • Pages : 219
  • Category : Philosophy
  • Reads : 686
  • File Pdf: tentacles-longer-than-night.pdf

Book Summary:

Our contemporary horror stories are written in a world where there seems little faith, lost hope, and no salvation. All that remains is the fragmentary and occasionally lyrical testimony of the human being struggling to confront its lack of reason for being in the vast cosmos. This is the terrain of the horror genre. Eugene Thacker explores this situation in Tentacles Longer Than Night. Extending the ideas presented in his book In The Dust of This Planet, Thacker considers the relationship between philosophy and the horror genre. But instead of taking fiction as the mere illustration of ideas, Thacker reads horror stories as if they themselves were works of philosophy, driven by a speculative urge to question human knowledge and the human-centric view of the world, ultimately leading to the limit of the human - thought undermining itself, in thought. Tentacles Longer Than Night is the third volume of the "horror of philosophy" trilogy, together with the first volume, In The Dust of This Planet, and the second volume, Starry Speculative Corpse.

The Strange Case of Dr. Couney

By Dawn Raffel
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Penguin
  • Isbn : 0698404815
  • Pages : 304
  • Category : Biography & Autobiography
  • Reads : 529
  • File Pdf: the-strange-case-of-dr-couney.pdf

Book Summary:

“A mosaic mystery told in vignettes, cliffhangers, curious asides, and some surreal plot twists as Raffel investigates the secrets of the man who changed infant care in America.”—NPR, 2018's Great Reads What kind of doctor puts his patients on display? This is the spellbinding tale of a mysterious Coney Island doctor who revolutionized neonatal care more than one hundred years ago and saved some seven thousand babies. Dr. Martin Couney's story is a kaleidoscopic ride through the intersection of ebullient entrepreneurship, enlightened pediatric care, and the wild culture of world's fairs at the beginning of the American Century. As Dawn Raffel recounts, Dr. Couney used incubators and careful nursing to keep previously doomed infants alive, while displaying these babies alongside sword swallowers, bearded ladies, and burlesque shows at Coney Island, Atlantic City, and venues across the nation. How this turn-of-the-twentieth-century émigré became the savior to families with premature infants—known then as “weaklings”—as he ignored the scorn of the medical establishment and fought the rising popularity of eugenics is one of the most astounding stories of modern medicine. Dr. Couney, for all his entrepreneurial gusto, is a surprisingly appealing character, someone who genuinely cared for the well-being of his tiny patients. But he had something to hide... Drawing on historical documents, original reportage, and interviews with surviving patients, Dawn Raffel tells the marvelously eccentric story of Couney's mysterious carnival career, his larger-than-life personality, and his unprecedented success as the savior of the fragile wonders that are tiny, tiny babies. A New York Times Book Review New & Noteworthy Title A Real Simple Best Book of 2018 Christopher Award-winner

Anemia, An Issue of Medical Clinics of North America, E-Book

By Thomas G. DeLoughery
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Elsevier Health Sciences
  • Isbn : 0323509991
  • Pages :
  • Category : Medical
  • Reads : 339
  • File Pdf: anemia-an-issue-of-medical-clinics-of-north-america-e-book.pdf

Book Summary:

This issue of Medical Clinics, guest edited by Dr. Thomas G. DeLoughery, is devoted to anemia. Articles in this issue include: Anemia: Evaluation and Diagnostic Tests; Anemia of Chronic Disease; B12/Folate Deficiency; Iron Deficiency; Myelodysplasia; Autoimmune Hemolytic Anemia; Congenital Hemolytic Anemia; Sickle Cell Disease; Thrombotic Microangiopathy; Unusual Anemias; and Transfusion Therapy.

Price Setting and Price Regulation in Health Care

By OECD,World Health Organization,Barber Sarah L,Lorenzoni Luca,Ong Paul
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : OECD Publishing
  • Isbn : 9264508864
  • Pages : 298
  • Category :
  • Reads : 846
  • File Pdf: price-setting-and-price-regulation-in-health-care.pdf

Book Summary:

The objectives of this study are to describe experiences in price setting and how pricing has been used to attain better coverage, quality, financial protection, and health outcomes. It builds on newly commissioned case studies and lessons learned in calculating prices, negotiating with providers, and monitoring changes. Recognising that no single model is applicable to all settings, the study aimed to generate best practices and identify areas for future research, particularly in low- and middle-income settings. The report and the case studies were jointly developed by the OECD and the WHO Centre for Health Development in Kobe (Japan).

The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

By S.R. Walker,C. Lumley,N. McAuslane
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Isbn : 940111420X
  • Pages : 262
  • Category : Medical
  • Reads : 883
  • File Pdf: the-relevance-of-ethnic-factors-in-the-clinical-evaluation-of-medicines.pdf

Book Summary:

For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.

Medical Device Regulatory Practices

By Val Theisz
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Isbn : 9814669113
  • Pages : 590
  • Category : Medical
  • Reads : 368
  • File Pdf: medical-device-regulatory-practices.pdf

Book Summary:

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Principles of Medical Therapy in Pregnancy

By Norbert Gleicher
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Isbn : 1461324157
  • Pages : 1320
  • Category : Medical
  • Reads : 979
  • File Pdf: principles-of-medical-therapy-in-pregnancy.pdf

Book Summary:

Prefaces of textbooks are generally meant to give editors an opportunity to express the rationale for the creation of yet another textbook. It is rare to find an author or editor who does not believe that his/her book fills a very specific need. This editor is no exception. With the incredible proliferation of medical textbooks in recent years, it has become difficult to find an empty niche for yet another text. Nevertheless, the editors and authors of Principles of Medical Therapy in Pregnancy have been impressed by one very clearly appreciated void: While the association of medical disorders with pregnancy is increasing in frequency as improved medical care allows more patients with medical diseases to conceive, an authoritative text covering the issue, comparable to an authoritative text in internal medicine, has been missing. With pregnancy representing a very specific disease situation-different from the nonpregnant state in diagnosis, management, and course of disease-a detailed textbook addressing all these issues for both the internist and the obstetrician seemed urgently needed.

Breakfast At Küsnacht

By Stefano Carpani
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Chiron Publications
  • Isbn : 1630518069
  • Pages : 278
  • Category : Psychology
  • Reads : 954
  • File Pdf: breakfast-at-küsnacht.pdf

Book Summary:

Breakfast at Küsnacht: Conversations on C.G. Jung and Beyond comprises a series of interviews with 10 Jungians and a special guest, Susie Orbach, feminist and relational psychotherapist. Each interview begins by asking them about the central steps of their intellectual biography/journey and which authors (or research areas) they consider essential for their own development and work (also beyond psychoanalysis). Therefore, when interviewing the Jungians, three basic questions were asked: (1) Who is Jung? Or, who is your Jung? (2) What is Jung´s relevance today? (3) What are dreams? These questions preceded a look into their own work and contributions. Themes contained within the book include: C.G. Jung´s work and his validity today; HIV and AIDS; Anima/Animus and Homosexuality; Alchemy; Dreams; Marie-Louise von Franz; Wolfgang Giegerich and Hegel; Otto Gross, the Personal and the Political; Individuation; Painting, Drawing and the Unconscious; the Red Book; Relational Psychoanalysis; Women, Feminism, Love and Revolution; The application of the I-Ching in therapy; Becoming and Analyst.

The Howard Hughes Affair

By Stuart M. Kaminsky
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Open Road Media
  • Isbn : 1453232621
  • Pages : 210
  • Category : Fiction
  • Reads : 160
  • File Pdf: the-howard-hughes-affair.pdf

Book Summary:

On the eve of Pearl Harbor, Howard Hughes hires Hollywood gumshoe Toby Peters to find stolen blueprints in the “marvelously entertaining” series (Newsday). Millionaire Howard Hughes likes his secrets. He likes to keep them—and he definitely doesn’t like having them stolen. Hollywood PI Toby Peters has a rep for being discreet. So when the film tycoon and aviation magnate needs a detective to very privately investigate the theft of top-secret blueprints taken from his home during one of his fabulous parties, he summons Peters. But what starts as counter-espionage intrigue turns into a triple murder, and Peters soon finds himself bait for a killer. As America is pulled into World War II, Peters is just trying to stay alive as a gunman chases him through a deserted television soundstage. With help from some unlikely allies—including Basil Rathbone, the silver screen’s Sherlock Holmes, and gangster/patriot Bugsy Siegel—Peters is determined to dodge the bullets long enough to recover the blueprints before they fall into the wrong hands. The Chicago Sun-Times calls the Toby Peters mysteries “entertainment at its best” as Edgar Award–winning author Stuart Kaminsky takes readers on a rollicking tour of Hollywood in the forties.

Army Medical Officer's Guide

By Maj. Peter N. Fish MD USA
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Stackpole Books
  • Isbn : 0811711846
  • Pages : 160
  • Category : Reference
  • Reads : 171
  • File Pdf: army-medical-officer-s-guide.pdf

Book Summary:

• Guide to the duties, customs, organization, administration, resources, and benefits for medical officers in the U.S. Army • Practical information for officers on assuming command of a medical unit and taking on a mission • Training courses and requirements • Guidelines for interacting with patients

Army Medical Officer's Guide

By Peter N. Fish
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Stackpole Books
  • Isbn : 0811758656
  • Pages : 160
  • Category : Reference
  • Reads : 347
  • File Pdf: army-medical-officer-s-guide.pdf

Book Summary:

Guide to the duties, customs, organization, administration, resources, and benefits for medical officers in the U.S. Army.

Doctors, Honour and the Law

By A. Maehle
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Isbn : 0230234399
  • Pages : 198
  • Category : Science
  • Reads : 422
  • File Pdf: doctors-honour-and-the-law.pdf

Book Summary:

Medical ethics in Imperial Germany were entangled with professional, legal and social issues. This book shows how doctors' ethical decision-making was led by their notions of male honour, professional politics and a paternalistic doctor-patient relationship rather than concern for patients' interests or the right of the sick to self-determination.

Hidden Hands and Divided Landscapes

By Anoma Pieris
  • Format : Pdf, ePub, Mobi, Kindle
  • Publisher : University of Hawaii Press
  • Isbn : 082486283X
  • Pages : 416
  • Category : Social Science
  • Reads : 508
  • File Pdf: hidden-hands-and-divided-landscapes.pdf

Book Summary:

During the nineteenth century, the colonial Straits Settlements of Singapore, Penang, and Melaka were established as free ports of British trade in Southeast Asia and proved attractive to large numbers of regional migrants. Following the abolishment of slavery in 1833, the Straits government transported convicts from the East India Company’s Indian presidencies to the settlements as a source of inexpensive labor. The prison became the primary experimental site for the colonial plural society and convicts were graduated by race and the labor needed for urban construction. Hidden Hands and Divided Landscapes investigates how a political system aimed at managing ethnic communities in the larger material context of the colonial urban project was first imagined and tested through the physical segregation of the colonial prison. It relates the story of a city, Singapore, and a contemporary city-state whose plural society has its origins in these historical divisions. A description of the evolution of the ideal plan for a plural city across the three settlements is followed by a detailed look at Singapore’s colonial prison. Chapters trace the prison’s development and its dissolution across the urban landscape through the penal labor system. The author demonstrates the way in which racial politics were inscribed spatially in the division of penal facilities and how the map of the city was reconfigured through convict labor. Later chapters describe penal resistance first through intimate stories of penal life and then through a discussion of organized resistance in festival riots. Eventually, the plural city ideal collapsed into the hegemonic urban form of the citadel, where a quite different military vision of the city became evident. Hidden Hands and Divided Landscapes is a fascinating and thoroughly original study in urban history and the making of multiethnic society in Singapore. It will compel readers to rethink the ways in which colonial urban history, postcolonial urbanism, and governance have been theorized by scholars and represented by governments.