Global Clinical Trials for Alzheimer s Disease

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Read or download book entitled Global Clinical Trials for Alzheimer s Disease written by Menghis Bairu and published by Academic Press in PDF, EPUB and Kindle Format. Click Get This Book button to download or read online books. Join over 650.000 happy Readers and READ as many books as you like. We cannot guarantee that Global Clinical Trials for Alzheimer s Disease book is available in the library.

  • Publisher : Academic Press
  • Release : 28 August 2013
  • ISBN : 9780124115309
  • Page : 432 pages
  • Rating : 4.5/5 from 103 voters

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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 challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

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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 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

Alzheimer's Disease Drug Development

Alzheimer's Disease Drug Development
  • Author : Jeffrey Cummings,Jefferson Kinney,Howard Fillit
  • Publisher : Cambridge University Press
  • Release Date : 2022-03-31
  • ISBN : 9781108838665
GET THIS BOOKAlzheimer's Disease Drug Development

Provides a definitive overview of the complex ecosystem facilitating Alzheimer's Disease drug research and development. Demonstrates a drug's journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.

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

Re-Engineering Clinical Trials

Re-Engineering Clinical Trials
  • Author : Peter Schueler,Brendan Buckley
  • Publisher : Academic Press
  • Release Date : 2014-12-16
  • ISBN : 9780128007907
GET THIS BOOKRe-Engineering Clinical Trials

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

Alzheimer Disease

Alzheimer Disease
  • Author : Robert Becker,Ezio Giacobini
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • ISBN : 9781461241164
GET THIS BOOKAlzheimer Disease

Global Mental Health Trials

Global Mental Health Trials
  • Author : Graham Thornicroft,Vikram Patel
  • Publisher : Oxford University Press, USA
  • Release Date : 2014
  • ISBN : 9780199680467
GET THIS BOOKGlobal Mental Health Trials

Brings together many of the world's leading researchers active in the fields of randomized controlled trials (RCTs) in low- and medium-resource counties and settings related to improving mental health care to present clear and practical information about how to conduct such trials.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Jeffrey Cummings,Kate Zhong
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070406
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Globalization is increasingly common as a means of more rapidly recruiting patients, shortening clinical trials, abbreviating clinical development cycle times, and preparing for marketing in non-US markets. Globalization refers to the inclusion of trial sites in three or more international regions. Globalization is common and most drug development programs include both US and non-US sites. There has been limited evaluation of the transnational performance of clinical trial instrumentation used in drug development programs. The performance across nations, languages and cultures

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : James (Dachao) Fan,Li Huafang,Jing Yin
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070505
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

China has the largest number of people with dementia and the incidence is projected to increase much faster than in the developed world. There is a great demand for new drugs that can prevent or treat the disease and great potential for conducting Alzheimer’s disease clinical trials. The majority of Alzheimer’s disease trials that have been conducted in China are local trials. In early years, there were deficiencies in trial design and implementation; however, with more attention from

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Seong Yoon Kim
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070543
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Prevalence of dementia in Korea is 9.1% of the elderly population, and those with dementia are thus estimated to be nearly 750,000. Dementia due to Alzheimer’s disease (AD) accounts for 45–75% of all dementia syndromes, whereas vascular dementia accounts for about 12–37%. Clinical research on AD has been greatly expanded in volume and quality in the last 10 years in Korea, partly due to public and governmental awareness of the increase of the elderly population. The national drug market for dementia in 2020 is estimated

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,

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Ricardo F. Allegri,Pablo Bagnati,Sonia Brucki,Ricardo Nitrini
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070482
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Dementia is seriously disabling for those who have it and is often devastating for their caregivers and families. There are 7.7 million new cases of dementia each year, implying that there is a new case of dementia somewhere in the world every four seconds. The growth of dementia in the next 20 years will be much more acute in those countries with low and medium salaries. The World Health Organization wrote a report about dementia, calling on all governments to define dementia

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yoko Fujimoto,Takeshi Iwatsubo
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070536
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

Considering the difficulty of clinical development for Alzheimer’s Disease (AD), understanding each country’s specific situation is an important first step in reducing the operational burden on clinical trials while maintaining the quality of the study. In this chapter, the long history of clinical development for AD in Japan is introduced. There has been a lot of experience in Japan of AD clinical development from the time of developing donepezil to the current global development of AD disease-modifying drugs.

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Tal Burt,Lynne Hughes,Amir Kalali,P. Murali Doraiswamy
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070499
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

There is considerable interest, both nationally and internationally, in conducting dementia research in India. Motivated by a rapid increase in the aging population and a desire for indigenous, self-sufficient healthcare and medical research, dementia research in India is on course for rapid growth in the coming years. Several challenges will have to be overcome along the way. A solid and general clinical research culture and a supportive healthcare system, both tailored to the specific needs of the dementia field and

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Lynne Hughes,Spencer Guthrie
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-08-28
  • ISBN : 9780128070451
GET THIS BOOKGlobal Clinical Trials for Alzheimer’s Disease

This chapter reviews significant recent clinical trials involving potential disease-modifying drugs, including active immunotherapy, passive immunotherapy, γ-secretase inhibitors and modulators, β-secretase inhibitors, and amyloid-beta (Aβ) anti-aggregants. The challenges and opportunities involved in global trials are then discussed, such as variability in diagnosis and patient selection; patient endpoints for both symptomatic therapies and disease-modifying drugs; rater training and global validation of rating scales; competition to recruit the pool of patients available for clinical trials; and emerging logistical concerns related to the