December 4, 2020

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Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Release Date : 2008-07-25
Category : Medical
Total pages :560
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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
Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer
Release Date : 2022-02-27
Category : Medical
Total pages :129
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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
Author : John I. Gallin,Frederick P. Ognibene
Publisher : Academic Press
Release Date : 2007
Category : Science
Total pages :430
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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

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author : John I. Gallin,Frederick P. Ognibene
Publisher : Academic Press
Release Date : 2012
Category : Medical
Total pages :780
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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 of Good Clinical Practice

Principles of Good Clinical Practice
Author : Michael J. McGraw,Shawn P. Shearn
Publisher : Pharmaceutical Press
Release Date : 2010
Category : Medical
Total pages :256
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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
Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release Date : 2007-04-30
Category : Medical
Total pages :780
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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

Clinical Trials in Cancer

Clinical Trials in Cancer
Author : David J. Girling
Publisher : Oxford University Press, USA
Release Date : 2003
Category : Medical
Total pages :367
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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 Translational Science in Medicine

Principles of Translational Science in Medicine
Author : Martin Wehling
Publisher : Academic Press
Release Date : 2015-04-02
Category : Science
Total pages :364
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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

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine
Author : Lionel D. Edwards,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release Date : 2011-07-12
Category : Medical
Total pages :800
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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.

Pediatric Non-Clinical Drug Testing

Pediatric Non-Clinical Drug Testing
Author : Alan M. Hoberman,Elise M. Lewis
Publisher : John Wiley & Sons
Release Date : 2011-12-28
Category : Medical
Total pages :356
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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.

Principles and Practice of Clinical Parasitology

Principles and Practice of Clinical Parasitology
Author : Stephen Gillespie,Richard D. Pearson
Publisher : John Wiley & Sons
Release Date : 2003-01-24
Category : Medical
Total pages :680
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A comprehensive account of protozoan and metozoan diseases in modern clinical practice, with orientation towards clinical management of parasitic infections. In the past, parasitology was considered as an obscure subject of little relevance to the majority of clinicians and microbiologists. Over the last decade, however, much has happened to change this, not least the explosion in foreign travel This textbook is the forth in the Principles and Practice series, providing an expansive and detailed coverage of clinical microbiology. It has a similar appeal to that of Zuckerman's, Principles & Practice of Clinical Virology, with an international authorship and emphasis placed on integrating new knowledge in a clinically relevant manner. . An essential, up-to-date sourcebook on the fundamentals of human parasitology . Provides a global approach with renowned and international authorship . Completes the quartet of Principles and Practice series in Microbiology

The Principles and Practice of Narrative Medicine

The Principles and Practice of Narrative Medicine
Author : Rita Charon,Sayantani DasGupta,Nellie Hermann,Craig Irvine,Eric R Marcus,Edgar Rivera Colsn,Danielle Spencer,Maura Spiegel
Publisher : Oxford University Press
Release Date : 2016-11
Category :
Total pages :129
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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.

Principles and Practice of Phytotherapy

Principles and Practice of Phytotherapy
Author : Simon Mills,Simon Y. Mills,Kerry Bone
Publisher : Unknown
Release Date : 2000
Category : Medical
Total pages :643
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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

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

Emery and Rimoin’s Principles and Practice of Medical Genetics and Genomics
Author : Reed E. Pyeritz,Bruce R. Korf,Wayne W. Grody
Publisher : Academic Press
Release Date : 2020-11-01
Category : Medical
Total pages :790
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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

Clinical Psychopharmacology

Clinical Psychopharmacology
Author : Nassir Ghaemi
Publisher : Oxford University Press, USA
Release Date : 2019-01-04
Category : Medical
Total pages :600
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Clinical Psychopharmacology offers a comprehensive guide to clinical practice that explores two major aspects of the field: the clinical research that exists to guide clinical practice of psychopharmacology, and the application of that knowledge with attention to the individualized aspects of clinical practice. The text consists of 50 chapters, organized into 6 sections, focusing on disease-modifying effects, non-DSM diagnostic concepts, and essential facts about the most common drugs. This innovative book advocates a scientific and humanistic approach to practice and examines not only the benefits, but also the harms of drugs. Providing a solid foundation of knowledge and a great deal of practical information, this book is a valuable resource for practicing psychiatrists, psychiatric nurse practitioners, medical students and trainees in psychiatry, as well as pharmacists.