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Author: U Sahoo
Publisher: Elsevier
ISBN: 1908818131
Category : Medical
Languages : en
Pages : 412
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Book Description
Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research
Author: U Sahoo
Publisher: Elsevier
ISBN: 1908818131
Category : Medical
Languages : en
Pages : 412
Get Book Here
Book Description
Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309132967
Category : Medical
Languages : en
Pages : 359
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Book Description
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Author: Samiran Nundy
Publisher: Springer Nature
ISBN: 9811652481
Category : Medical
Languages : en
Pages : 475
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Book Description
This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.
Author: Jack Wong
Publisher: CRC Press
ISBN: 9814411213
Category : Medical
Languages : en
Pages : 618
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Book Description
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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Author: David Machin
Publisher: John Wiley & Sons
ISBN: 0470010150
Category : Mathematics
Languages : en
Pages : 784
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Book Description
Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.
Author: Chi-Jen Lee
Publisher: CRC Press
ISBN: 1420039148
Category : Medical
Languages : en
Pages : 520
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Book Description
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an
Author: Jack Wong
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 475
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Book Description
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.
Author: Arunaloke Chakrabarti
Publisher: Springer Nature
ISBN: 9811394598
Category : Medical
Languages : en
Pages : 339
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Book Description
This book discusses the unique epidemiology of fungal infections in Asia, illustrating that the situation in these countries is different from that in Western countries in terms of the causative species, natural history and management strategies. Asia, the world’s largest continent and home to more than half the global population, has conditions that favor the growth of many fungi, including a number of unique species. Further, socio-economic conditions such as overcrowding, compromised health care facilities and lack of awareness add to the morbidity and mortality due to fungal diseases in this part of the world. Since the majority of Asian countries do not have good diagnostic mycology laboratories, antifungal management is often based on experience. The limited data from Asian countries suggest a very high incidence of fungal infections. This book addresses epidemiology of fungal infections in general and specific populations of Asia, fungal allergy, and diagnosis and management in resource-limited environments. The book is must read for busy clinicians, microbiologists and critical care providers.
Author: Shirley Sun
Publisher: Routledge
ISBN: 1134989199
Category : Social Science
Languages : en
Pages : 139
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Book Description
The second decade of the twenty-first century has witnessed a surging interest in personalized medicine with the concomitant promise to enable more precise diagnosis and treatment of disease and illness, based upon an individual’s unique genetic makeup. In this book, my goal is to contribute to a growing body of literature on personalized medicine by tracing and analyzing how this field has blossomed in Asia. In so doing, I aim to illustrate how various social and economic forces shape the co-production of science and social order in global contexts. This book shows that there are inextricable transnational linkages between developing and developed countries and also provides a theoretically guided and empirically grounded understanding of the formation and usage of particular racial and ethnic human taxonomies in local, national and transnational settings. The Open Access version of this book, available at http://www.taylorfrancis.com/doi/view/10.4324/9781315537177 has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.
Author: David Hardiman
Publisher: Routledge
ISBN: 1136284028
Category : Political Science
Languages : en
Pages : 260
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Book Description
Examining the world of popular healing in South Asia, this book looks at the way that it is marginalised by the state and medical establishment while at the same time being very important in the everyday lives of the poor. It describes and analyses a world of ‘subaltern therapeutics’ that both interacts with and resists state-sanctioned and elite forms of medical practice. The relationship is seen as both a historical as well as ongoing one. Focusing on those who exist and practice in the shadow of statist medicine, the book discusses the many ways in which they try to heal a range of maladies, and how they experience their marginality. The contributors also provide a history of such therapeutics, in the process challenging the widespread belief that such ‘traditional’ therapeutics are relatively static and unchanging. In focusing on these problems of transition, they open up one of the central concerns of subaltern historiography. This is an important contribution to the history of medicine and society, and subaltern and South Asian studies.
