re engineering clinical trials

Re Engineering Clinical Trials
Author: Peter Schueler
Publisher: Academic Press
Release Date: 2014-12-16
Pages: 360
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

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 focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

NIH
Author: United States
Publisher:
Release Date: 2004
Pages: 54
ISBN:
Available Language: English, Spanish, And French
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Departments Of Labor  Health And Human Services  Education  And Related Agencies Appropriations For 2005
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher:
Release Date: 2004
Pages:
ISBN:
Available Language: English, Spanish, And French
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Neurosurgical Re Engineering Of The Damaged Brain And Spinal Cord
Author: Yoichi Katayama
Publisher: Springer Science & Business Media
Release Date: 2003-08-28
Pages: 186
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

This volume is the second in a new series of pro The task carried out through the collaboration of ceedings covering the official scientific meetings of the neurosurgeons and specialists in neurorehabilitation Neurorehabilitation Committee of the World Federa cannot be viewed simply as a restoration of function or tion of Neurosurgical Societies (WFNS). The first reconstruction of structure. Recent advances in neu scientific meeting of the WFNS Neurorehabilitation roimaging techniques have begun to demonstrate that Committee was held successfully in Munster, Ger it involves extensive functional and structural reorga many, in 2000 under the auspices of Professor Klaus nization of neural networks within the brain and R. H. von Wild. The proceedings of that meeting probably the spinal cord. On this basis, we felt that it (Functional Rehabilitation in Neurosurgery and Neu might be more appropriate to refer to such activities as rotraumatology) were published as a supplement to re-engineering of the damaged brain and spinal cord. Acta Neurochirurgica (volume 79, 2001). This first In order to encapsulate such a concept, the second scientific meeting highlighted the important role scientific meeting was entitled the Second Interna played by neurosurgeons in neurorehabilitation be tional Symposium on Neurosurgical Re-engineering of at an early period after brain or spinal cord the Damaged Brain and Spinal Cord (NRDBS'02). ginning damage.

Departments Of Labor  Health And Human Services  Education  And Related Agencies Appropriations For 2006  Department Of Labor
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher:
Release Date: 2005
Pages:
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Innovation In Clinical Trial Methodologies
Author: Peter Schueler
Publisher: Academic Press
Release Date: 2020-11-01
Pages: 202
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

Re Engineering Of The Damaged Brain And Spinal Cord
Author: Klaus R.H. Wild
Publisher: Springer Science & Business Media
Release Date: 2007-08-09
Pages: 240
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Traumatic Brain Injury (TBI) can lead to loss of skills and to mental cognitive behavioural deficits. Paraplegia after Spinal Cord Injury (SCI) means a life-long sentence of paralysis, sensory loss, dependence and in both, TBI and SCI, waiting for a miracle therapy. Recent advances in functional neurosurgery, neuroprosthesis, robotic devices and cell transplantation have opened up a new era. New drugs and reconstructive surgical concepts are on the horizon. Social reintegration is based on holistic rehabilitation. Psychological treatment can alleviate and strengthen affected life. This book reflects important aspects of physiology and new trans-disciplinary approaches for acute treatment and rehabilitation in neurotraumatology by reviewing evidence based concepts as they were discussed among bio and gene-technologists, physicians, neuropsychologists and other therapists at the joint international congress in Brescia 2004.

Medical Imaging
Author: Mostafa Analoui
Publisher: CRC Press
Release Date: 2012-11-08
Pages: 454
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

The discovery of x-ray, as a landmark event, enabled us to see the "invisible," opening a new era in medical diagnostics. More importantly, it offered a unique undestanding around the interaction of electromagnetic signal with human tissue and the utility of its selective absorption, scattering, diffusion, and reflection as a tool for understanding the physiology, evolution of disease, and therapy. With contributions from world-class experts, Medical Imaging: Principles and Practices offers a review of key imaging modalities with established clinical utilization and examples of quantitative tools for image analysis, modeling, and interpretation. The book provides a detailed overview of x-ray imaging and computed tomography, fundamental concepts in signal acquisition and processes, followed by an overview of functional MRI (fMRI) and chemical shift imaging. It also covers topics in Magnetic Resonance Microcopy, the physics of instrumentation and signal collection, and their application in clinical practice. Highlights include a chapter offering a unique perspective on the use of quantitative PET for its applications in drug discovery and development, which is rapidly becoming an indispensible tool for clinical and research applications, and a chapter addressing the key issues around organizing and searching multimodality data sets, an increasingly important yet challenging issue in clinical imaging. Topics include: X-ray imaging and computed tomography MRI and magnetic resonance microscopy Nuclear imaging Ultrasound imaging Electrical Impedance Tomography (EIT) Emerging technologies for in vivo imaging Contrast-enhanced MRI MR approaches for osteoarthritis and cardiovascular imaging PET quantitative imaging for drug development Medical imaging data mining and search The selection of topics provides readers with an appreciation of the depth and breadth of the field and the challenges ahead of the technical and clinical community ofresearchers and practitioners.

Departments Of Labor  Health And Human Services  Education  And Related Agencies Appropriations For 2006
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher:
Release Date: 2005
Pages:
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Social Work Practice Research For The Twenty First Century
Author: Anne E. Fortune
Publisher: Columbia University Press
Release Date: 2010-09-21
Pages: 320
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Social work professionals must demonstrate their effectiveness to legislators and governments, not to mention clients and incoming practitioners. A thorough evaluation of the activities, ethics, and outcomes of social work practice is critical to maintaining investment and interest in the profession and improving the lives of underserved populations. Incorporating the concerns of a new century into a consideration of models for practice research, this volume builds on the visionary work of William J. Reid (1928-2003) who transformed social work research through empirically based and task-centered approaches-and, more recently, synthesized intervention knowledge for framing future study. This collection reviews the task-centered model and other contemporary Evidence-Based Practice models for working with individuals, families, groups, communities, and organizations. Essays demonstrate the value of these pragmatic approaches in the United States and international settings. Contributors summarize state-of-the-art methods in several key fields of service, including children and families, aging, substance abuse, and mental health. They also evaluate the research movement itself, outlining an agenda for today's sociopolitical landscape and the profession. This volume inspires practice research to prioritize evidence as a base for the profession.

Translational Medicine   What  Why And How
Author: Barbara Alving
Publisher: Karger Medical and Scientific Publishers
Release Date: 2012-12-01
Pages: 126
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

This book is the first to provide an aerial view, as well as detailed information, on 'how' activities in translational medicine are under development in countries such as the USA, China, the UK, and Taiwan. Institutions in each country are training investigators to work as sophisticated interdisciplinary teams. Investigators from 11 US academic health centers explain how they are incentivizing collaborations through pilot project programs, forming partnerships with business schools to promote efficient management of basic and clinical research, creating ethical, high- value public-private (industry) partnerships, improving efficiency with utilization of informatics, and engaging the community in research. The essential role of evaluation is explained in a clear and concise manner. The readers will also learn about the role of private funding in Taiwan and the vision of the government in China in developing multiple translational research centers. The UK is developing methodical approaches to patient needs across their lifespans; ongoing innovation is encouraged through incubator programs. With the emphasis on open innovation and sharing, the concepts and practice of translational medicine are spreading rapidly on an international scale.

Nurses Making Policy
Author: Rebecca M. Patton, DNP, RN, CNOR, FAAN
Publisher: Springer Publishing Company
Release Date: 2014-11-13
Pages: 568
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

"There is a plethora of policy books on the market, but none illustrate the steps in the policy process better than this one. The high caliber editors and contributors, all of whom have been involved in policy work, bring years of experience to illustrate the key points... This publication is timely as the shift in healthcare requires input from all health professionals, but especially nurses who are at the frontline of healthcare change and delivery. This outstanding resource will help motivate many more nurses to get involved in the policy process... Weighted Numerical Score: 93 - 4 Stars!"--Doody's Medical Reviews Written by those in the knowñexceptional nurse leaders in practice, education, and politicsñthis is a practical, "how-to" book written to help advanced students and nurse leaders develop health policy skills to advocate for patients from the bedside to the larger political arena. Co-published with the American Nurses Association (ANA), the book examines the pivotal role of nurses' involvement in health policy and describes the requisite steps for facilitating policy changeñfrom understanding the political system through activating a plan and beyond. It features the voices of a wide variety of nurse leaders who discuss policy work both locally and nationally through descriptive case histories. The book discusses those qualities and skill sets that are needed for advocacy at the bedside and other arenas where health policy is determined. It examines the political system and opportunities for nurse involvement, and clarifies the process of identifying issues that need a policy solution. Because citing research is an integral component of health policy solutions, the book describes how research can be used to strengthen policy initiatives. The book guides the reader step by step through the process of creating a work plan and describes the resources needed to accomplish policy change. Activating an action plan and strategies for working with the media are covered, along with the process of taking a leadership role, evaluating outcomes, using policy to eliminate health inequities, and maintaining and expanding momentum. Woven throughout the book are the major themes of ethics, leadership, safety, and the quest for quality of care. The text provides information and perspectives relevant to the American Association of Colleges of Nursing (AACN) doctor of nursing practice (DNP) Essentials, and includes multimedia electronic links to resources (podcasts, online articles, social network resources, and key political websites) that promote policy research and leadership development. KEY FEATURES: Delineates the steps to becoming a policy advocate in organizational, educational, and political settings Written by noted nurse leaders who describe policy work locally and nationally Presents competencies for nursing policy work derived from the AACN DNP Essentials Focuses throughout on themes of ethics, leadership, quality, and safety Facilitates web use for policy research and development Ancillary materials from the editors are available

Handbook Of Evidence Based Practice In Clinical Psychology  Adult Disorders
Author: Michel Hersen
Publisher: John Wiley & Sons
Release Date: 2012-08-02
Pages: 768
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Handbook of Evidence-Based Practice in Clinical Psychology, Volume 2 covers the evidence-based practices now identified for treating adults with a wide range of DSM disorders. Topics include fundamental issues, adult cognitive disorders, substance-related disorders, psychotic, mood, and anxiety disorders, and sexual disorders. Each chapter provides a comprehensive review of the evidence-based practice literature for each disorder and then covers several different treatment types for clinical implementation. Edited by the renowned Peter Sturmey and Michel Hersen and featuring contributions from experts in the field, this reference is ideal for academics, researchers, and libraries.

Public Health Effectiveness Of The FDA 510 K  Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Release Date: 2010-10-04
Pages: 140
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Flow Cytometry In Drug Discovery And Development
Author: Virginia Litwin
Publisher: John Wiley & Sons
Release Date: 2011-04-20
Pages: 360
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

Brain Injury Medicine
Author: Douglas I Katz, MD
Publisher: Demos Medical Publishing
Release Date: 2006-10-16
Pages: 176
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

A Doody's Core Title 2012 Brain Injury Medicine: Principles and Practice is a comprehensive guide to all aspects of the management issues involved in caring for the person with brain injury - from early diagnosis and evaluation through the post-acute period and rehabilitation. It is the definitive core text needed by all practitioners in this area, including physiatrists, neurologists, psychologists, nurses, and other health care professionals. Written by over 100 acknowledged leaders in the field, and containing hundreds of tables, graphs, and photographic images, the text deals with issues of neuroimaging and neurodiagnostic testing, prognosis and outcome, acute care, rehabilitative care, treatment of specific populations, neurologic problems following injury, neuromusculoskeletal problems, and general management issues. Key features include: Emphasis on a disease state management approach to patient assessment and treatment Promotion of a holistic, biopsychosocial model of patient assessment and care Review of current expert consensus on practice guidelines Exploration of epidemiologic and basic pathophysiologic aspects of brain injury Examination of clinical issues throughout the continuum of rehabilitative care Cutting edge, practical information based on the authors' extensive clinical experience that will positively impact patients and families following brain injury

Preclinical Safety Evaluation Of Biopharmaceuticals
Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
Release Date: 2013-03-07
Pages: 1064
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe selection of the first human doses. With chapters contributedby experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach toFacilitating Clinical Trials: Includes an overview of biopharmaceuticals with information onregulation and methods of production Discusses the principles of ICH S6 and their implementation inthe U.S., Europe, and Japan Covers current practices in preclinical development andincludes a comparison of safety assessments for small moleculeswith those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process,including: the selection of relevant species; safety/toxicityendpoints; specific considerations based upon class; and practicalconsiderations in the design, implementation, and analysis ofbiopharmaceuticals Covers transitioning from preclinical development to clinicaltrials This is a hands-on, straightforward reference for professionalsinvolved in preclinical drug development, including scientists,toxicologists, project managers, consultants, and regulatorypersonnel.

Nutritional Genomics
Author: Jim Kaput
Publisher: John Wiley & Sons
Release Date: 2006-04-28
Pages: 480
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

The definitive guide to the basic principles and latest advances inNutritional Genomics Though still in its infancy, nutritional genomics, or"nutrigenomics," has revealed much about the complex interactionsbetween diet and genes. But it is in its potential applicationsthat nutrigenomics promises to revolutionize the ways we managehuman health and combat disease in the years ahead. Great progressalready has been made in modeling "personalized" nutrition foroptimal health and longevity as well as in genotype-based dietaryinterventions for the prevention, mitigation, or possible cure of avariety of chronic diseases and some types of cancer. Topics covered include: * Nutrients and gene expression * The role of metabolomics in individualized health * Molecular mechanisms of longevity regulation and calorierestriction * Green tea polyphenols and soy peptides in cancer prevention * Maternal nutrition and fetal gene expression * Genetic susceptibility to heterocyclic amines from cookedfoods * Bioinformatics and biocomputation in nutrigenomics * The pursuit of optimal diets Written by an all-star team of experts from around the globe, thisvolume provides an integrated overview of the cutting-edge field ofnutritional genomics. The authors and editors lead an in-depthdiscussion of the fundamental principles and scientificmethodologies that serve as the foundation for nutritional genomicsand explore important recent advances in an array of relateddisciplines. Each self-contained chapter builds upon itspredecessor, leading the reader seamlessly from basic principles tomore complex scientific findings and experimental designs.Scientific chapters are carefully balanced with those addressingthe social, ethical, regulatory, and commercial implications ofnutrigenomics.

Clinical Engineering Handbook
Author: Joseph Dyro
Publisher: Elsevier
Release Date: 2004-09-15
Pages: 696
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The profession of clinical engineering continues to seek its place amidst the myriad of professionals that comprise the health care field. The Clinical Engineering Handbook meets a long felt need for a comprehensive book on all aspects of clinical engineering that is a suitable reference in hospitals, classrooms, workshops, and governmental and non-governmental organization. The Handbook’s thirteen sections address the following areas: Clinical Engineering; Models of Clinical Engineering Practice; Technology Management; Safety Education and Training; Design, Manufacture, and Evaluation and Control of Medical Devices; Utilization and Service of Medical Devices; Information Technology; and Professionalism and Ethics. The Clinical Engineering Handbook provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. From telemedicine and IT issues, to sanitation and disaster planning, it brings together all the important aspects of clinical engineering. Clinical Engineers are the safety and quality faciltators in all medical facilities The most definitive, comprehensive, and up-to-date book available on the subject of clinical engineering Over 170 contributions by leaders in the field of clinical engineering

Food Allergy In Children  An Issue Of Pediatric Clinics   E Book
Author: Hemant Sharma
Publisher: Elsevier Health Sciences
Release Date: 2011-05-12
Pages: 244
ISBN:
Available Language: English, Spanish, And French
EBOOK SYNOPSIS:

Dr. Coppes and his co-Editors have created a comprehensive table of contents that addresses the full spectrum of food allergies in children. Articles are presented to be most useful to pediatricians, as the issue begins with the clinical presentation and epidemiology of food allergy, and then progresses to the diagnostic testing and pahthophysiology. Articles are also included that are devoted to specific types of food allergy, dairy, soy, egg, peanut, and tree nut. Finally, articles are also devoted to living with food allergies, management of allergies in schools and camps, and therapies for food allergies.