July 7, 2022
Medical Regulatory Affairs Book

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Medical Regulatory Affairs

By Jack Wong,Raymond K. Y. Tong
  • ISBN Code: : 1000440516
  • Publisher : CRC Press
  • Pages : 806
  • Category : Medical
  • Reads : 115
  • Book Compatibility : Pdf, ePub, Mobi, Kindle
  • Pdf : medical-regulatory-affairs.pdf

Book Excerpt :

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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  • Book Code : 0802146872
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  • Pdf File: code-blue.pdf

Book Short Summary:

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Better Now

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  • Pdf File: better-now.pdf

Book Short 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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  • Pdf File: regulatory-affairs-in-the-pharmaceutical-industry.pdf

Book Short Summary:

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

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  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1498761313
  • Total of Pages : 416
  • Category : Mathematics
  • Members : 408
  • Pdf File: economic-evaluation-of-cancer-drugs.pdf

Book Short 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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  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : iUniverse
  • Book Code : 1491797622
  • Total of Pages : 150
  • Category : Science
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  • Pdf File: nesiritide.pdf

Book Short Summary:

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  • Total of Pages : 360
  • Category : Medical
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  • Pdf File: re-engineering-clinical-trials.pdf

Book Short Summary:

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

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  • Pdf File: biotechnology.pdf

Book Short Summary:

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  • Pdf File: when-is-a-medical-product-too-risky.pdf

Book Short Summary:

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  • Book Code : 0323918239
  • Total of Pages : 534
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  • Pdf File: safety-risk-management-for-medical-devices.pdf

Book Short Summary:

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

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  • Publisher : Random House Canada
  • Book Code : 0307372081
  • Total of Pages : 560
  • Category : Fiction
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  • Pdf File: cutting-for-stone.pdf

Book Short Summary:

International Bestseller A sweeping, emotionally riveting first novel — an enthralling family saga of Africa and America, doctors and patients, exile and home. Marion and Shiva Stone are twin brothers born of a secret union between a beautiful Indian nun and a brash British surgeon at a mission hospital in Addis Ababa. Orphaned by their mother’s death in childbirth and their father’s disappearance, bound together by a preternatural connection and a shared fascination with medicine, the twins come of age as Ethiopia hovers on the brink of revolution. Yet it will be love, not politics — their passion for the same woman — that will tear them apart and force Marion, fresh out of medical school, to flee his homeland. He makes his way to America, finding refuge in his work as an intern at an underfunded, overcrowded New York City hospital. When the past catches up to him — nearly destroying him — Marion must entrust his life to the two men he thought he trusted least in the world: the surgeon father who abandoned him and the brother who betrayed him. An unforgettable journey into one man’s remarkable life, and an epic story about the power, intimacy, and curious beauty of the work of healing others.

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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
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : National Academies Press
  • Book Code : 0309452996
  • Total of Pages : 582
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  • Pdf File: communities-in-action.pdf

Book Short 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.

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  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 135171287X
  • Total of Pages : 227
  • Category : Medical
  • Members : 362
  • Pdf File: conceptualising-public-health.pdf

Book Short 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 Good Doctor

By Kenneth Brigham,Michael M. E. Johns
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Seven Stories Press
  • Book Code : 1609809971
  • Total of Pages : 224
  • Category : Medical
  • Members : 248
  • Pdf File: the-good-doctor.pdf

Book Short Summary:

What makes a good doctor? It's not what you think. A doctor willing to face their own uncertainty in the face of illness and treatment might just be the best medicine. Too often we choose the wrong doctor for the wrong reasons. It doesn't have to be that way. In The Good Doctor, Ken Brigham, MD, and Michael M.E. Johns, MD, argue that we need to change the way we think about health care if we want to be the healthiest we can be. Counterintuitive as it may seem, uncertainty is integral to medicine, and you want a doctor who knows that: someone who sees you as the unique case you are, someone who knows that data isn't everything, someone who is able to change her mind as the information changes. For too long we've clung to the myth of the infallible doctor--one who assuredly tells us this is what's wrong and here is how I will cure you--and our health has suffered for it. Brigham and Johns propose a new model of medicine, one that is comfortable with ambiguity and that centers on an equal partnership between patient and doctor. Uncertainty, properly embraced, opens a new universe of possibilities.

Real-World Evidence in the Pharmaceutical Landscape

By Sunil Dravida,Abhishek Dabral,Jugal Sharma
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Gatekeeper Press
  • Book Code : 1662914091
  • Total of Pages : 286
  • Category : Technology & Engineering
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  • Pdf File: real-world-evidence-in-the-pharmaceutical-landscape.pdf

Book Short Summary:

In Real-World Evidence in the Pharmaceutical Landscape, life science industry experts Sunil Dravida and his co-authors have developed the first comprehensive overview of its kind on Real-World Data (RWD) in the pharmaceutical industry. The authors examine the challenges and opportunities in applying real-world data along the pharmaceutical continuum, from clinical development to medical affairs, health economics and outcomes, and marketing. They address the difficulties identifying the suitable data sources, ensuring compliance with privacy, security and regulatory requirements, and the big job of translating data into Real-World Evidence (RWE) to generate meaningful insights that can improve decision making by stakeholders and measurable outcomes that can enhance people’s health and well-being. This book is a must-read for those in the pharmaceutical industry involved with RWD, which includes just about every role, as healthcare is now dominated by the need for high-quality data that can enable better decision-making. This book is especially critical for those designing and leading RWD Centers of Excellence in pharmaceutical companies and the service providers supporting the RWD ecosystem.

Conflict of Interest in Medical Research, Education, and Practice

By Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : National Academies Press
  • Book Code : 0309145449
  • Total of Pages : 436
  • Category : Medical
  • Members : 243
  • Pdf File: conflict-of-interest-in-medical-research-education-and-practice.pdf

Book Short Summary:

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

The Identity of the History of Science and Medicine

By Andrew Cunningham
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  • Publisher : Routledge
  • Book Code : 1351219529
  • Total of Pages : 284
  • Category : Science
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  • Pdf File: the-identity-of-the-history-of-science-and-medicine.pdf

Book Short 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.

Bop Apocalypse

By Martin Torgoff
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  • Category : History
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  • Pdf File: bop-apocalypse.pdf

Book Short 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
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 0429922485
  • Total of Pages : 176
  • Category : Psychology
  • Members : 313
  • Pdf File: the-trainings-of-the-psychoanalyst.pdf

Book Short 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?

Medical Device Regulatory Practices

By Val Theisz
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 9814669113
  • Total of Pages : 590
  • Category : Medical
  • Members : 502
  • Pdf File: medical-device-regulatory-practices.pdf

Book Short 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.

On the Nature of Health

By L.Y Nordenfelt
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 9401577684
  • Total of Pages : 204
  • Category : Medical
  • Members : 438
  • Pdf File: on-the-nature-of-health.pdf

Book Short 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.

Transcultural Humanities in South Asia

By Waseem Anwar
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Routledge
  • Book Code : 1000539156
  • Total of Pages : 516
  • Category : Literary Criticism
  • Members : 732
  • Pdf File: transcultural-humanities-in-south-asia.pdf

Book Short 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
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Hunt Publishing
  • Book Code : 1782798889
  • Total of Pages : 219
  • Category : Philosophy
  • Members : 347
  • Pdf File: tentacles-longer-than-night.pdf

Book Short 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
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Penguin
  • Book Code : 0698404815
  • Total of Pages : 304
  • Category : Biography & Autobiography
  • Members : 359
  • Pdf File: the-strange-case-of-dr-couney.pdf

Book Short 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

The Era of Artificial Intelligence, Machine Learning, and Data Science in the Pharmaceutical Industry

By Stephanie K. Ashenden
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Book Code : 0128204494
  • Total of Pages : 264
  • Category : Computers
  • Members : 237
  • Pdf File: the-era-of-artificial-intelligence-machine-learning-and-data-science-in-the-pharmaceutical-industry.pdf

Book Short Summary:

The Era of Artificial Intelligence, Machine Learning and Data Science in the Pharmaceutical Industry examines the drug discovery process, assessing how new technologies have improved effectiveness. Artificial intelligence and machine learning are considered the future for a wide range of disciplines and industries, including the pharmaceutical industry. In an environment where producing a single approved drug costs millions and takes many years of rigorous testing prior to its approval, reducing costs and time is of high interest. This book follows the journey that a drug company takes when producing a therapeutic, from the very beginning to ultimately benefitting a patient’s life. This comprehensive resource will be useful to those working in the pharmaceutical industry, but will also be of interest to anyone doing research in chemical biology, computational chemistry, medicinal chemistry and bioinformatics. Demonstrates how the prediction of toxic effects is performed, how to reduce costs in testing compounds, and its use in animal research Written by the industrial teams who are conducting the work, showcasing how the technology has improved and where it should be further improved Targets materials for a better understanding of techniques from different disciplines, thus creating a complete guide

Dictionary of Pharmaceutical Medicine

By Gerhard Nahler
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 3709140161
  • Total of Pages : 179
  • Category : Medical
  • Members : 413
  • Pdf File: dictionary-of-pharmaceutical-medicine.pdf

Book Short 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.

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

By Thomas G. DeLoughery
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Elsevier Health Sciences
  • Book Code : 0323509991
  • Total of Pages :
  • Category : Medical
  • Members : 902
  • Pdf File: anemia-an-issue-of-medical-clinics-of-north-america-e-book.pdf

Book Short 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.

Value Creation in the Pharmaceutical Industry

By Alexander Schuhmacher,Markus Hinder,Oliver Gassmann
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 3527693416
  • Total of Pages : 508
  • Category : Science
  • Members : 508
  • Pdf File: value-creation-in-the-pharmaceutical-industry.pdf

Book Short Summary:

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

By S.R. Walker,C. Lumley,N. McAuslane
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 940111420X
  • Total of Pages : 262
  • Category : Medical
  • Members : 557
  • Pdf File: the-relevance-of-ethnic-factors-in-the-clinical-evaluation-of-medicines.pdf

Book Short 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.

Principles of Medical Therapy in Pregnancy

By Norbert Gleicher
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 1461324157
  • Total of Pages : 1320
  • Category : Medical
  • Members : 590
  • Pdf File: principles-of-medical-therapy-in-pregnancy.pdf

Book Short 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.

Principles of Clinical Pharmacology

By Arthur J. Atkinson, Jr.,Darrell R. Abernethy,Charles E. Daniels,Robert Dedrick,Sanford P. Markey
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Elsevier
  • Book Code : 9780080466422
  • Total of Pages : 568
  • Category : Medical
  • Members : 908
  • Pdf File: principles-of-clinical-pharmacology.pdf

Book Short Summary:

This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered by the American Board of Clinical Pharmacology. This unique reference is recommended by the Board as a study text and includes modules on drug discovery and development to assist students as well as practicing pharmacologists. Unique breadth of coverage ranging from drug discovery and development to individualization and quality assessment of drug therapy Unusual cohesive of presentation that stems from author participation in an ongoing popular NIH course Instructive linkage of pharmacokinetic theory and applications with provision of sample problems for self-study Wide-ranging perspective of authors drawn from the ranks of Federal agencies, academia and the pharmaceutical industry Expanded coverage of pharmacogenetics Expanded coverage of drug transporters and their role in interactions Inclusion of new material on enzyme induction mechanisms in chapters on drug metabolism and drug interactions A new chapter on drug discovery that focuses on oncologic agents Inclusion of therapeutic antibodies in chapter on biotechnology products

Breakfast At Küsnacht

By Stefano Carpani
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Chiron Publications
  • Book Code : 1630518069
  • Total of Pages : 278
  • Category : Psychology
  • Members : 727
  • Pdf File: breakfast-at-küsnacht.pdf

Book Short 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.