Global Clinical Trials Playbook

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  • Publisher : Academic Press
  • Release : 20 April 2012
  • ISBN : 9780124157873
  • Page : 332 pages
  • Rating : 4.5/5 from 103 voters

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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 guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

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Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher : Academic Press
  • Release Date : 2012-04-20
  • ISBN : 9780124157873
GET THIS BOOKGlobal 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

Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher : Academic Press
  • Release Date : 2012-06-12
  • ISBN : 9780124158603
GET THIS BOOKGlobal 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

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2016-07-14
  • ISBN : 0128103558
GET THIS BOOKGlobal 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

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher : Academic Press
  • Release Date : 2013-08-28
  • ISBN : 9780124115309
GET THIS BOOKGlobal 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

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070529
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Sidney A. Spector
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070567
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression of isoenzymes of the cytochrome P-450 enzyme system explains a significant amount of the variability of inter-individual responses to medicines. In Alzheimer’s disease, the highly variable clinical response to cholinesterase inhibitors metabolized by the liver is explained on this basis. More recently, translation of basic pharmacogenomic research through the drug development process has led to the approval of ”personalized“ medicines,

Clinical Practice Guidelines We Can Trust

Clinical Practice Guidelines We Can Trust
  • Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
  • Publisher : National Academies Press
  • Release Date : 2011-06-16
  • ISBN : 9780309216463
GET THIS BOOKClinical Practice Guidelines We Can Trust

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice

Novel Designs of Early Phase Trials for Cancer Therapeutics

Novel Designs of Early Phase Trials for Cancer Therapeutics
  • Author : Shivaani Kummar,Chris Takimoto
  • Publisher : Academic Press
  • Release Date : 2018-05-22
  • ISBN : 9780128125700
GET THIS BOOKNovel Designs of Early Phase Trials for Cancer Therapeutics

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
  • Author : Richard Chin,Bruce Y Lee
  • Publisher : Elsevier
  • Release Date : 2008-07-25
  • ISBN : 0080557937
GET THIS BOOKPrinciples and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting

The Law of Off-label Uses of Medicines

The Law of Off-label Uses of Medicines
  • Author : Andrea Parziale
  • Publisher : Taylor & Francis
  • Release Date : 2022-08-12
  • ISBN : 9781000634389
GET THIS BOOKThe Law of Off-label Uses of Medicines

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

The Practical Playbook

The Practical Playbook
  • Author : J. Lloyd Michener,Denise Koo,Brian C. Castrucci,James Baird Sprague
  • Publisher : Oxford University Press, USA
  • Release Date : 2016
  • ISBN : 9780190222147
GET THIS BOOKThe Practical Playbook

Why a practical playbook for partnerships between public health and primary care? / Denise Koo, J. Lloyd Michener, James B. Sprague, Brian C. Castrucci -- The value of public health and primary care partnerships / Brian C. Castrucci, J. Lloyd Michener, Densie Koo, James B. Sprague -- Primary care and public health: partners for population health / Julie K. Wood -- The value of integration : public health, primary care, and beyond / Paul E. Jarris, Katie Sellers -- Principles of partnerships between public health

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care
  • Author : Abdul Kader Mohiuddin
  • Publisher : Universal-Publishers
  • Release Date : 2020
  • ISBN : 9781627343084
GET THIS BOOKThe Role of the Pharmacist in Patient Care

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development

Nutrients in Infancy

Nutrients in Infancy
  • Author : Colin Binns,Mi Kyung Lee,Masaharu Kagawa
  • Publisher : MDPI
  • Release Date : 2018-07-04
  • ISBN : 9783038425601
GET THIS BOOKNutrients in Infancy

This book is a printed edition of the Special Issue "Nutrients in Infancy" that was published in Nutrients

The Practical Playbook II

The Practical Playbook II
  • Author : J. Lloyd Michener,Brian C. Castrucci,Don W. Bradley,Edward L. Hunter,Craig W. Thomas,Catherine Patterson,Elizabeth Corcoran
  • Publisher : Oxford University Press
  • Release Date : 2019-04-23
  • ISBN : 9780190936020
GET THIS BOOKThe Practical Playbook II

The definitive guide to the secret sauce of improving public and population health Nontraditional collaborations have produced some of the most sweeping, health-improving results in recent memory. But whether it's public/private, cross-discipline, or interagency, the formula for identifying these partnerships -- not to mention making them work -- remains very much in progress. The Practical Playbook II is the first resource to elucidate what works (and what doesn't) when it comes to collaborating for change in and around health.

National Strategy for the COVID-19 Response and Pandemic Preparedness

National Strategy for the COVID-19 Response and Pandemic Preparedness
  • Author : Joseph R. Biden, Jr.
  • Publisher : Simon and Schuster
  • Release Date : 2021-05-18
  • ISBN : 9781510767614
GET THIS BOOKNational Strategy for the COVID-19 Response and Pandemic Preparedness

The ultimate guide for anyone wondering how President Joe Biden will respond to the COVID-19 pandemic—all his plans, goals, and executive orders in response to the coronavirus crisis. Shortly after being inaugurated as the 46th President of the United States, Joe Biden and his administration released this 200 page guide detailing his plans to respond to the coronavirus pandemic. The National Strategy for the COVID-19 Response and Pandemic Preparedness breaks down seven crucial goals of President Joe Biden's administration with