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Principles And Practice Of Clinical Trial Medicine

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Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine Book
Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Release : 2008-07-25
ISBN : 9780080557939
Language : En, Es, Fr & De

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Book Description :

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 results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Book
Author : John I. Gallin,Frederick P. Ognibene
Publisher : Academic Press
Release : 2012
ISBN : 0123821673
Language : En, Es, Fr & De

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Book Description :

This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials Book
Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer
Release : 2022-02-27
ISBN : 9783319526355
Language : En, Es, Fr & De

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Book Description :

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the analysis and interpretation of scientific data gleaned from the trial process, a broad spectrum of clinical trial principles and practice areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy cannot be guaranteed and regulated without the Clinical Trials process. Because of an immense and continuing to grow international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives2) Regulation and Oversight3) Basic Trial Designs4) Advanced Trial Designs5) Analysis6) Trial Publication7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Clinical Trials in Cancer

Clinical Trials in Cancer Book
Author : David J. Girling
Publisher : Oxford University Press, USA
Release : 2003
ISBN : 9780192629593
Language : En, Es, Fr & De

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Book Description :

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. DEGREESNL This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

Principles of Good Clinical Practice

Principles of Good Clinical Practice Book
Author : Michael J. McGraw,Shawn P. Shearn
Publisher : Pharmaceutical Press
Release : 2010
ISBN : 0853697906
Language : En, Es, Fr & De

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Book Description :

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine Book
Author : Lionel D. Edwards,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release : 2011-07-12
ISBN : 1444348124
Language : En, Es, Fr & De

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Book Description :

The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine Book
Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release : 2007-04-30
ISBN : 9780470093146
Language : En, Es, Fr & De

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Book Description :

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

The Principles and Practice of Clinical Trials

The Principles and Practice of Clinical Trials Book
Author : Books on Demand
Publisher : Unknown
Release : 2021-09-21
ISBN : 9780598253750
Language : En, Es, Fr & De

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Book Description :

Download The Principles and Practice of Clinical Trials book written by Books on Demand, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Global Clinical Trials Playbook

Global Clinical Trials Playbook Book
Author : Menghis Bairu,Richard Chin
Publisher : Academic Press
Release : 2012-06-12
ISBN : 0124158609
Language : En, Es, Fr & De

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Book Description :

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

Success in Academic Surgery Clinical Trials

Success in Academic Surgery  Clinical Trials Book
Author : Timothy M. Pawlik,Julie A. Sosa
Publisher : Springer Science & Business Media
Release : 2013-11-04
ISBN : 1447146794
Language : En, Es, Fr & De

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Book Description :

Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine Book
Author : Andrew J. Fletcher,Lionel D. Edwards,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release : 2003-01-31
ISBN : 0470851716
Language : En, Es, Fr & De

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Book Description :

Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. * The authors are all experts in their field and include an assessment of the current status of their specialities * This book provides an insight into how things may develop in the future * It is designed to be a guide for those who are actually practicing pharmaceutical medicine

Clinical Trials

Clinical Trials Book
Author : Timothy M. Pawlik,Julie A. Sosa
Publisher : Springer Nature
Release : 2020-03-10
ISBN : 3030354881
Language : En, Es, Fr & De

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Book Description :

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Clinical Trials in Older Adults

Clinical Trials in Older Adults Book
Author : Antonio Cherubini,Roberto Bernabei,Luigi Ferrucci,Niccolò Marchionni,Stephanie Studenski,Bruno Vellas
Publisher : John Wiley & Sons
Release : 2016-01-13
ISBN : 1118323475
Language : En, Es, Fr & De

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Book Description :

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer

Cancer Research and Clinical Trials in Developing Countries

Cancer Research and Clinical Trials in Developing Countries Book
Author : Daniela Cristina Stefan
Publisher : Springer
Release : 2015-12-16
ISBN : 3319184431
Language : En, Es, Fr & De

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Book Description :

This book describes the principles around which cancer research and clinical trials can be developed. Additionally, by describing the particularities of planning and implementing cancer research in developing countries, this book provides valuable practical information for researchers in resource-rich countries who contemplate cooperating with scientists from limited-resource countries in performing research.Written and edited by leaders in the field who work in these developing countries, Cancer Research and Clinical Trials in Developing Countries: A Practical Guide will appeal to a wide range of researchers, students, and physicians who are engaging in cancer research and clinical trials. It focuses on methodology and statistics while structured around the needs of cancer research. It provides valuable information regarding international collaboration, funding mechanisms as well as publishing and dissemination of research findings.

Principles and Practice of Phytotherapy E Book

Principles and Practice of Phytotherapy   E Book Book
Author : Kerry Bone,Simon Mills
Publisher : Elsevier Health Sciences
Release : 2013-01-08
ISBN : 0702052973
Language : En, Es, Fr & De

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Book Description :

The authoritative and comprehensive modern textbook on western herbal medicine - now in its second edition This long-awaited second edition of Principles and Practice of Phytotherapy covers all major aspects of herbal medicine from fundamental concepts, traditional use and scientific research through to safety, effective dosage and clinical applications. Written by herbal practitioners with active experience in clinical practice, education, manufacturing and research, the textbook is both practical and evidence based. The focus, always, is on the importance of tailoring the treatment to the individual case. New insights are given into the herbal management of approxiately 100 modern ailments, including some of the most challenging medical conditions, such as asthma, inflammatory bowel disease and other complex autoimmune and inflammatory conditions, and there is vibrant discussion around the contribution of phytotherapy in general to modern health issues, including health ageing. Fully referenced throughout, with more than 10, 000 citations, the book is a core resource for students and practitioners of phytotherapy and naturopathy and will be of value to all healthcare professionals - pharmacists, doctors, nurses - with an interest in herbal therapeutics. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interaction chart. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interaction chart.

Global Clinical Trials

Global Clinical Trials Book
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Release : 2011-05-06
ISBN : 9780123815385
Language : En, Es, Fr & De

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Book Description :

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 countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Oxford Textbook of Geriatric Medicine

Oxford Textbook of Geriatric Medicine Book
Author : Jean-Pierre Michel,Jeremy D. Walston
Publisher : Oxford University Press
Release : 2017-12-14
ISBN : 0198701594
Language : En, Es, Fr & De

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Book Description :

Over the past two decades there has been a marked change in global age demographics, with the number of over-60s increasing by 82% and the number of centenarians by 715%. This new-found longevity is testament to the success of recent advances in medicine, but poses significant challenges to multiple areas of health care concerning older patients. Building upon its predecessor's reputation as the definitive resource on the subject, this new edition of the Oxford Textbook of Geriatric Medicine offers a comprehensive and multinational examination of the field. Fully revised to reflect the current state of geriatric medicine, it examines the medical and scientific basis of clinical issues, as well as the ethical, legal, and socio-economic concerns for healthcare policy and systems. Over 170 chapters are broken up into 16 key sections, covering topics ranging from policy and key concepts through to infection, cancer, palliative medicine, and healthy ageing. New material includes focus on the evolving concepts of malnutrition, sarcopenia, frailty, and related geriatric syndromes and integration of geriatric principles from public health, primary and specialized care, and transitional stages from home to emergency, medicine and surgery, rehabilitation, and long term care. The Oxford Textbook of Geriatric Medicine brings together specialists from across the globe to provide every physician involved in the care of older patients with a comprehensive resource on all the clinical problems they are likely to encounter, as well as on related psychological, philosophical, and social issues.

The Principles and Practice of Clinical Trials

The Principles and Practice of Clinical Trials Book
Author : Christopher Saxty Good,Association of Medical Advisers in the Pharmaceutical Industry
Publisher : Unknown
Release : 1976
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Principles and Practice of Clinical Trials book written by Christopher Saxty Good,Association of Medical Advisers in the Pharmaceutical Industry, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Adaptive and Flexible Clinical Trials

Adaptive and Flexible Clinical Trials Book
Author : Richard Chin
Publisher : CRC Press
Release : 2016-04-19
ISBN : 143983833X
Language : En, Es, Fr & De

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Book Description :

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.

Principles and Practice of Multi Agent Systems

Principles and Practice of Multi Agent Systems Book
Author : Nirmit Desai,Alan Liu,Michael Winikoff
Publisher : Springer Science & Business Media
Release : 2012-01-09
ISBN : 3642259197
Language : En, Es, Fr & De

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Book Description :

This book constitutes the thoroughly refereed post-conference proceedings of the 13th International Conference on Principles and Practice of Multi-Agent Systems, PRIMA 2010, held in Kolkata, India, in November 2010. The 18 full papers presented together with 15 early innovation papers were carefully reviewed and selected from over 63 submissions. They focus on practical aspects of multiagent systems and cover topics such as agent communication, agent cooperation and negotiation, agent reasoning, agent-based simulation, mobile and semantic agents, agent technologies for service computing, agent-based system development, ServAgents workshop, IAHC workshop, and PRACSYS workshop.