Clinical Research in Asia
Clinical Research in Asia

Author: U Sahoo

Publisher: Elsevier

Published: 2012-05-25

Total Pages: 412

ISBN-13: 1908818131

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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

Crossing the Quality Chasm
Crossing the Quality Chasm

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-07-19

Total Pages: 359

ISBN-13: 0309132967

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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.

Clinical Trials of Drugs and Biopharmaceuticals
Clinical Trials of Drugs and Biopharmaceuticals

Author: Chi-Jen Lee

Publisher: CRC Press

Published: 2005-09-19

Total Pages: 520

ISBN-13: 1420039148

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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

How to Practice Academic Medicine and Publish from Developing Countries?
How to Practice Academic Medicine and Publish from Developing Countries?

Author: Samiran Nundy

Publisher: Springer Nature

Published: 2021-10-23

Total Pages: 475

ISBN-13: 9811652481

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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.

Handbook of Medical Device Regulatory Affairs in Asia
Handbook of Medical Device Regulatory Affairs in Asia

Author: Jack Wong

Publisher: CRC Press

Published: 2018-03-28

Total Pages: 475

ISBN-13: 0429996764

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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.

Handbook of Medical Device Regulatory Affairs in Asia
Handbook of Medical Device Regulatory Affairs in Asia

Author: Jack Wong

Publisher: CRC Press

Published: 2013-03-27

Total Pages: 618

ISBN-13: 9814411213

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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.

Clinical Practice of Medical Mycology in Asia
Clinical Practice of Medical Mycology in Asia

Author: Arunaloke Chakrabarti

Publisher: Springer Nature

Published: 2019-11-16

Total Pages: 339

ISBN-13: 9811394598

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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.

Textbook of Clinical Trials
Textbook of Clinical Trials

Author: David Machin

Publisher: John Wiley & Sons

Published: 2007-01-11

Total Pages: 784

ISBN-13: 0470010150

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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.

Public Health in Asia and the Pacific
Public Health in Asia and the Pacific

Author: Milton J. Lewis

Publisher: Routledge

Published: 2007-10-19

Total Pages: 333

ISBN-13: 1134240562

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The Asia-Pacific region has not only the greatest concentration of population but is, arguably, the future economic centre of the world. Epidemiological transition in the region is occurring much faster than it did in the West and many countries face the emerging problem of chronic diseases at the same time as they continue to grapple with communicable diseases. This book explores how disease patterns and health problems in Asia and the Pacific, and collective responses to them, have been shaped over time by cultural, economic, social, demographic, environmental and political factors. With fourteen chapters, each devoted to a country in the region, the authors take a comparative and historical approach to the evolution of public health and preventive medicine, and offer a broader understanding of the links in a globalizing world between health on the one hand and culture, economy, polity and society on the other. Public Health in Asia and the Pacific presents the importance of the non-medical context in the history of human disease, as well as the significance of disease in the larger histories of the region. It will appeal to scholars and policy makers in the fields of public health, the history of medicine, and those with a wider interest in the Asia-Pacific region.

Drug Discovery and Clinical Research
Drug Discovery and Clinical Research

Author: SK Gupta

Publisher: JP Medical Ltd

Published: 2011-06

Total Pages: 659

ISBN-13: 9350252724

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The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.