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Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine

by Richard Chin,Bruce Y Lee

  • Publisher : Elsevier
  • Release : 2008-07-25
  • Pages : 560
  • ISBN : 9780080557939
  • Language : En, Es, Fr & De
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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 Trials

Principles and Practice of Clinical Trials

by Steven Piantadosi,Curtis L. Meinert

  • Publisher : Springer
  • Release : 2022-02-27
  • Pages : 329
  • ISBN : 9783319526355
  • Language : En, Es, Fr & De
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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.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research

by John I. Gallin,Frederick P. Ognibene

  • Publisher : Academic Press
  • Release : 2012
  • Pages : 780
  • ISBN : 0123821673
  • Language : En, Es, Fr & De
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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 Research

Principles and Practice of Clinical Research

by John I. Gallin,Frederick P. Ognibene

  • Publisher : Academic Press
  • Release : 2007
  • Pages : 430
  • ISBN : 9780123694409
  • Language : En, Es, Fr & De
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The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Clinical Trials in Cancer

Clinical Trials in Cancer
Principles and Practice

by David J. Girling

  • Publisher : Oxford University Press, USA
  • Release : 2003
  • Pages : 367
  • ISBN : 9780192629593
  • Language : En, Es, Fr & De
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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

by Michael J. McGraw,Shawn P. Shearn

  • Publisher : Pharmaceutical Press
  • Release : 2010
  • Pages : 256
  • ISBN : 0853697906
  • Language : En, Es, Fr & De
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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

by Lionel D. Edwards,Anthony W. Fox,Peter D. Stonier

  • Publisher : John Wiley & Sons
  • Release : 2011-07-12
  • Pages : 800
  • ISBN : 1444348124
  • Language : En, Es, Fr & De
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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

by Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier

  • Publisher : John Wiley & Sons
  • Release : 2007-04-30
  • Pages : 780
  • ISBN : 9780470093146
  • Language : En, Es, Fr & De
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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

Davidson's Principles and Practice of Medicine E-Book

Davidson's Principles and Practice of Medicine E-Book

by Stuart H. Ralston,Ian D Penman,Mark W J Strachan,Richard Hobson

  • Publisher : Elsevier Health Sciences
  • Release : 2018-02-02
  • Pages : 1456
  • ISBN : 0702070262
  • Language : En, Es, Fr & De
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More than two million medical students, doctors and other health professionals around the globe have owned a copy of Davidson’s Principles and Practice of Medicine since it was first published. Now in its 23rd Edition, this textbook describes the pathophysiology and clinical features of the most frequently encountered conditions in the major specialties of adult medicine and explains how to recognise, investigate, diagnose and manage them. Taking its origins from Sir Stanley Davidson’s much-admired lecture notes, Davidson’s has endured because it keeps pace with how modern medicine is taught and provides a wealth of information in an easy-to-read, concise and beautifully illustrated format. This book will serve readers everywhere as a core text that integrates medical science with clinical medicine, conveying key knowledge and practical advice in a highly accessible and readable format. The opening section describes the fundamentals of genetics, immunology, infectious diseases and population health, and discusses the core principles of clinical decision-making and good prescribing. A new second section on emergency and critical care medicine encompasses poisoning, envenomation and environmental medicine, and introduces a new chapter on acute medicine and critical illness. The third section covers the major medical specialties, each thoroughly revised and brought fully up to date. Two new chapters on maternal and adolescent/transition medicine complement the one on ageing and disease. A new chapter on medical ophthalmology has been included. Clinical Examination overviews summarise the main elements for each system and now feature in the biochemistry, nutrition and dermatology chapters. Presenting Problems sections provide a clear pathway for the assessment of and approach to the most common complaints in each specialty. Practice Point summaries detail the practical skills that medical students and junior doctors must acquire. Emergency boxes emphasise the core knowledge needed to manage acutely ill patients. In Old Age, In Pregnancy and In Adolescence boxes highlight differences in the practice of medicine in these patient groups, and illustrate the interfaces between medical, obstetric and paediatric services. The text is extensively illustrated, with over 1000 diagrams, clinical photographs, and radiology and pathology images. The global perspective is enhanced by an International Advisory Board of experts from 17 countries, and by authors from around the world.

Principles of Translational Science in Medicine

Principles of Translational Science in Medicine
From Bench to Bedside

by Martin Wehling

  • Publisher : Academic Press
  • Release : 2015-04-02
  • Pages : 364
  • ISBN : 0128007214
  • Language : En, Es, Fr & De
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Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

Pediatric Non-Clinical Drug Testing

Pediatric Non-Clinical Drug Testing
Principles, Requirements, and Practice

by Alan M. Hoberman,Elise M. Lewis

  • Publisher : John Wiley & Sons
  • Release : 2011-12-28
  • Pages : 356
  • ISBN : 1118168259
  • Language : En, Es, Fr & De
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This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

The Principles and Practice of Narrative Medicine

The Principles and Practice of Narrative Medicine

by Rita Charon,Sayantani DasGupta,Nellie Hermann,Craig Irvine,Eric R Marcus,Edgar Rivera Colsn,Danielle Spencer,Maura Spiegel

  • Publisher : Oxford University Press
  • Release : 2016-11
  • Pages : 329
  • ISBN : 0199360197
  • Language : En, Es, Fr & De
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Narrative medicine is a fresh discipline of health care that helps patients and health professionals to tell and listen to the complex and unique stories of illness. The Principles and Practice of Narrative Medicine expresses the collective experience and discoveries of the originators of the field. Arising at Columbia University in 2000 from roots in the humanities and patient-centered care, narrative medicine draws patients, doctors, nurses, therapists, and health activists together to re-imagine a health care based on trust and trustworthiness, humility, and mutual recognition. Over a decade of education and research has crystallized the goals and methods of narrative medicine, leading to increasingly powerful means to improve the care that patients receive. The methods described in this book harness creativity and insight to help the professionals in being with patients, not just to diagnose and treat them but to bear witness to what they undergo. Narrative medicine training in literary theory, philosophy, narrative ethics, and the creative arts increases clinicians' capacity to perceive the turmoil and suffering borne by patients and to help them to cohere or endure the chaos of illness. Narrative medicine has achieved an international reputation and reach. Many health care settings adopt methods of narrative medicine in teaching and practice. Through the Master of Science in Narrative Medicine graduate program and health professions school curricula at Columbia University, more and more clinicians and scholars have obtained the rigorous training necessary to practice and teach narrative medicine. This text is offered to all who seek the opportunity for disciplined training in narrative medicine. By clearly articulating our principles and practice, this book provides the standards of the field for those who want to join us in seeking authenticity, recognition, affiliation, and justice in a narrative health care.

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research
Applied Theory and Practice Using Case Studies

by Felipe Fregni,Ben M. W. Illigens

  • Publisher : Oxford University Press
  • Release : 2018
  • Pages : 518
  • ISBN : 0199324492
  • Language : En, Es, Fr & De
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Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Principles and Practice of Phytotherapy

Principles and Practice of Phytotherapy
Modern Herbal Medicine

by Simon Mills,Simon Y. Mills,Kerry Bone

  • Publisher :
  • Release : 2000
  • Pages : 643
  • ISBN :
  • Language : En, Es, Fr & De
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This book provides a detailed, practical and, where possible, research-based rationale for the use of herbal treatments in a wide variety of clinical conditions and problems. Through the filter of current scientific literature, the authors have reevaluated traditional use of herbal remedies and present realistic guidelines for modern practice. A uniquely authoritative guide to applying herbal medicines as serious options for the treatment of some of the most troublesome conditions seen today. In particular, this book gives: * A clear description of the principles and foundations for the practice of phytotherapy * In-depth and detailed profiles of over 45 herbs, reviewing pharmacology, research, and traditional use * Therapeutics for actual disease states, supported by case histories *Coverage of challenging issues such as dosage, safety, and drug-herb interactions

Neuroepidemiology

Neuroepidemiology
From Principles to Practice

by Lorene M. Nelson

  • Publisher : Oxford University Press
  • Release : 2004
  • Pages : 461
  • ISBN : 019513379X
  • Language : En, Es, Fr & De
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This fine text provides a comprehensive overview of methods for epidemiologic and clinical research on neurological disorders. The book focuses on classic principles of study design in epidemiologic research, strategies for avoiding study biases, methods for conducting clinical trials and prognostic studies, and principles of evidence-based medicine in neurology. The text gives neurologists, epidemiologists, and their students the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders.

Emery and Rimoin’s Principles and Practice of Medical Genetics and Genomics

Emery and Rimoin’s Principles and Practice of Medical Genetics and Genomics
Metabolic Disorders

by Reed E. Pyeritz,Bruce R. Korf,Wayne W. Grody

  • Publisher : Academic Press
  • Release : 2020-11-01
  • Pages : 790
  • ISBN : 0128126833
  • Language : En, Es, Fr & De
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For decades, Emery and Rimoin’s Principles and Practice of Medical Genetics and Genomics has served as the ultimate resource for clinicians integrating genetics into medical practice. With nearly 5,000 pages of detailed coverage, contributions from over 250 of the world’s most trusted authorities in medical genetics, and a series of 11 volumes available for individual sale, the Seventh Edition of this classic reference includes the latest information on seminal topics such as prenatal diagnosis, genome and exome sequencing, public health genetics, genetic counseling, and management and treatment strategies to complete its coverage of this growing field for medical students, residents, physicians, and researchers involved in the care of patients with genetic conditions. This comprehensive yet practical resource emphasizes theory and research fundamentals related to applications of medical genetics across the full spectrum of inherited disorders and applications to medicine more broadly. In Metabolic Disorders, leading physicians and researchers thoroughly examine medical genetics as applied to a range of metabolic disorders, with emphasis on understanding the genetic mechanisms underlying these disorders, diagnostic approaches, and therapeutics that make use of current genomic technologies and translational studies. Here genetic researchers, students, and health professionals will find new and fully revised chapters on the genetic basis of body mass, amino acid, carbohydrate, iron, copper, lipo protein, and lipid metabolic disorders, as well as organic acidemias, fatty acid oxidation, and peroxisome disorders among others. With regular advances in genomic technologies propelling precision medicine into the clinic, Emery and Rimoin’s Principles and Practice of Medical Genetics and Genomics: Seventh Edition bridges the gap between high-level molecular genetics and practical application and serves as an invaluable clinical tool for health professionals and researchers. Wholly revised and up-to-date, this volume thoroughly addresses medical genetics and genomics as applied to metabolic disorders, with emphasis on understanding the genetic mechanisms underlying these disorders, diagnostic approaches, and treatment methods Provides genetic researchers, students, and health professionals with up-to-date coverage on the genetic basis of a range of metabolic disorders, including body mass, amino acid, carbohydrate, iron, copper, lipo protein, and lipid metabolic disorders, as well as organic acidemias, fatty acid oxidation, and peroxisome disorders among others Includes color images supporting identification, concept illustration, and method processing Features contributions by leading international researchers and practitioners of medical genetics A robust companion website offers lecture slides, image banks, and links to outside resources and articles to stay up-to-date on the latest developments in the field

Principles and Practice of Hospital Medicine

Principles and Practice of Hospital Medicine

by Sylvia McKean,Daniel D. Dressler,John Ross,Daniel Brotman,Jeffrey Ginsberg

  • Publisher : McGraw Hill Professional
  • Release : 2012
  • Pages : 2310
  • ISBN : 0071603891
  • Language : En, Es, Fr & De
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The goal of the book is provide trainees, junior and senior clinicians, and other professionals with a comprehensive resource that they can use to improve care processes and performance in the hospitals that serve their communities. Includes case studies.

Principles and Practice of Travel Medicine

Principles and Practice of Travel Medicine

by Jane N. Zuckerman

  • Publisher : John Wiley & Sons
  • Release : 2012-12-07
  • Pages : 680
  • ISBN : 1118392078
  • Language : En, Es, Fr & De
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This second edition of Principles and Practice of Travel Medicine has been extensively updated to provide a comprehensive description of travel medicine and is an invaluable reference resource to support the clinical practice of travel medicine. This new edition covers the many recent advances in the field, including the development of new and combined vaccines; malaria prophylaxis; emerging new infections; new hazards resulting from travel to long haul destinations; health tourism; and population movements. The chapter on vaccine-preventable diseases includes new developments in licensed vaccines, as well as continent-based recommendations for their administration. There are chapters on the travel health management of high risk travellers, including the diabetic traveller, the immuno-compromised, those with cardiovascular, renal, neurological, gastrointestinal, malignant and other disorders, psychological and psychiatric illnesses, pregnant women, children and the elderly. With increasing numbers of ever more adventurous travellers, there is discussion of travel medicine within extreme environments, whilst the chapter on space tourism may well be considered the future in travel medicine. Principles and Practice of Travel Medicine is an invaluable resource for health care professionals providing advice and clinical care to the traveller.

Intraperitoneal Cancer Therapy

Intraperitoneal Cancer Therapy
Principles and Practice

by Wim P. Ceelen,Edward Levine

  • Publisher : CRC Press
  • Release : 2015-10-22
  • Pages : 423
  • ISBN : 1482261197
  • Language : En, Es, Fr & De
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Intraperitoneal Cancer Therapy: Principles and Practice is one of the first books to combine the latest clinical developments in the treatment of patients with peritoneal surface disease and the scientific principles that underlie the concept of intraperitoneal cancer therapy. The book covers basic concepts such as anatomy, physiology, pharmacology

The Principles and Practice of Medicine

The Principles and Practice of Medicine

by John D. Stobo,David B. Hellmann,Paul W. Ladenson,Thomas A. Traill,Brent G. Petty

  • Publisher : McGraw-Hill/Appleton & Lange
  • Release : 1996-06-24
  • Pages : 1046
  • ISBN :
  • Language : En, Es, Fr & De
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Completely rewritten by the internal medicine faculty as Johns Hopkins, this is a brand-new version of Harvey's classic book.