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Global Clinical Trials
  • Language: en
  • Pages: 537

Global Clinical Trials

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various cou...

Global Clinical Trials Playbook
  • Language: en
  • Pages: 332

Global Clinical Trials Playbook

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step gu...

Global Clinical Trials for Alzheimer's Disease
  • Language: en
  • Pages: 428

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer's disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenge...

Socio-economics of Personalized Medicine in Asia
  • Language: en
  • Pages: 211

Socio-economics of Personalized Medicine in Asia

  • Type: Book
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  • Published: 2016-07-01
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  • Publisher: Routledge

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.

Plunkett's Nanotechnology & Mems Industry Almanac 2008: Nanotechnology & Mems Industry Market Research, Statistics, Trends & Leading Companies
  • Language: en
  • Pages: 453

Plunkett's Nanotechnology & Mems Industry Almanac 2008: Nanotechnology & Mems Industry Market Research, Statistics, Trends & Leading Companies

Nanotechology has applications within biotechnology, manufacturing, aerospace, information systems and many other fields. This book covers such nanotechnology business topics as micro-electro-mechanical systems, microengineering, microsystems, microsensors, and carbon tubes. It also includes statistical tables, an industry glossary and indexes.

The Law of Off-label Uses of Medicines
  • Language: en
  • Pages: 183

The Law of Off-label Uses of Medicines

  • Categories: Law

This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarif...

Plunkett's Biotech & Genetics Industry Almanac
  • Language: en
  • Pages: 602

Plunkett's Biotech & Genetics Industry Almanac

A complete market research guide to the business of biotech, genetics, proteomics and related services--a tool for strategic planning, competitive intelligence, employment searches, or financial research. Complete profiles of nearly 400 leading biotech companies, in-depth chapters on trends. Includes glossary thorough indexes, statistics, research and development, emerging technology--as well a addresses, phone numbers, and executive names.

The Cancer Lifeline Cookbook
  • Language: en
  • Pages: 252

The Cancer Lifeline Cookbook

After 30 years of providing counseling and support for people living with cancer, the Cancer Lifeline organization knows that one of the main areas of interest for patients and their families is food and nutrition. What foods have been shown to help prevent the spread of cancer? What are the nutritional "rules" for people with cancer? In answer, this new edition of the organization's cookbook presents up-to-date nutritional information (including the Top Ten Super Foods that may protect and fight against cancer) along with practical strategies for making healthy eating a daily practice and suggestions for reducing the side effects of treatment. It features 100 easy-to-make recipes from the nation's top chefs and from some cancer patients and survivors, including Blueberry Breakfast Cake, Honey-Glazed Green Beans with Almonds, and Citrus Chicken. These resources and more make it a natural choice for cancer survivors, people living with cancer, and those interested in a health-conscious diet.

Alzheimer's Disease
  • Language: en
  • Pages: 164

Alzheimer's Disease

Alzheimer's disease was discovered over 100 years ago and still belongs to incurable neurological diseases; its pharmacotherapy is considered to be ineffective. This book presents contemporary views on the genetic, biochemical, and immunological determinants of this disease. This book also concerns the issue of Alzheimer's disease prevention through lifestyle and physical activity. Moreover, it describes the therapies used in Alzheimer's disease to slow the progression of the disease and delay its onset. Subsequently, the authors discuss experimental and clinical trials used now and in the near future. We hope that this book will help the readers to understand the complex mechanism leading to the development of Alzheimer's disease and indicate effective ways to prevent this disorder.

Global Clinical Trials for Alzheimer’s Disease
  • Language: en
  • Pages: 11

Global Clinical Trials for Alzheimer’s Disease

Data from clinical trials in emerging markets are becoming a standard component of the regulatory package being provided to support pharmaceutical marketing authorizations including the FDA New Drug Application (NDA) and the EMA Marketing Authorization Application (MAA). In this chapter, the highlights of the requirements for Alzheimer’s disease interventions are summarized, including a review of trial enrichment strategies. The topic of acceptance of foreign clinical data is also reviewed.