November 25, 2020

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Re-Engineering Clinical Trials

Re-Engineering Clinical Trials
Author : Peter Schueler,Brendan Buckley
Publisher : Academic Press
Release Date : 2014-12-16
Category : Medical
Total pages :360
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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

NIH
Author : United States,United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Release Date : 2004
Category : Electronic books
Total pages :54
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Innovation in Clinical Trial Methodologies

Innovation in Clinical Trial Methodologies
Author : Peter Schueler
Publisher : Academic Press
Release Date : 2020-11-01
Category : Medical
Total pages :202
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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

Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2004

Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2004
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies
Publisher : Unknown
Release Date : 2003
Category : United States
Total pages :129
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Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2005

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 : Unknown
Release Date : 2004
Category : United States
Total pages :129
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Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2006: Department of Labor

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 : Unknown
Release Date : 2005
Category : United States
Total pages :129
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Clinical Data Management

Clinical Data Management
Author : Richard K. Rondel,Sheila A. Varley,Colin F. Webb
Publisher : John Wiley & Sons
Release Date : 2000-02-03
Category : Medical
Total pages :366
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Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

Neurosurgical Re-Engineering of the Damaged Brain and Spinal Cord

Neurosurgical Re-Engineering of the Damaged Brain and Spinal Cord
Author : Yoichi Katayama
Publisher : Springer Science & Business Media
Release Date : 2003-08-28
Category : Medical
Total pages :186
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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.

Medical Imaging

Medical Imaging
Author : Mostafa Analoui,Joseph D. Bronzino,Donald R. Peterson
Publisher : CRC Press
Release Date : 2012-11-08
Category : Medical
Total pages :454
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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

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 : Unknown
Release Date : 2005
Category : United States
Total pages :129
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Translational Medicine - What, Why and How

Translational Medicine - What, Why and How
Author : Barbara Alving,Kerong Dai,Samuel H. H. Chan
Publisher : Karger Medical and Scientific Publishers
Release Date : 2012-12-01
Category : Science
Total pages :126
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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.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Release Date : 2010-10-04
Category : Medical
Total pages :140
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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.

Handbook of Evidence-Based Practice in Clinical Psychology, Adult Disorders

Handbook of Evidence-Based Practice in Clinical Psychology, Adult Disorders
Author : Michel Hersen,Peter Sturmey
Publisher : John Wiley & Sons
Release Date : 2012-08-02
Category : Psychology
Total pages :768
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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.

Brain Injury Medicine

Brain Injury Medicine
Author : Douglas I Katz, MD,Ross D Zafonte, DO,Nathan D Zasler, MD, FAAPM&R, FAADEP, DAAPM
Publisher : Demos Medical Publishing
Release Date : 2006-10-16
Category : Medical
Total pages :176
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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

Preclinical Safety Evaluation of Biopharmaceuticals
Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Release Date : 2013-03-07
Category : Medical
Total pages :1064
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"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.