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Curtis Meinert L Clinical Trials Dictionary - tachka-naprokat.ru
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Curtis Meinert L. Clinical Trials Dictionary. Terminology and Usage Recommendations


A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.

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Curtis Meinert L. Clinical Trials Handbook. Design and Conduct


A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

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Группа авторов Dictionary for Clinical Trials


As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials. This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials. Wide ranging, brief, pragmatic explanations of clinical trial terminology Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology Thoroughly revised and expanded – increase of 280 terms from First Edition, reference to Cochrane included From the reviews of the First Edition: «This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts… Fully comprehensive – provides definitions of clinical trial terms in one complete volume… Includes extensive use of graphs throughout.» LA DOC STI «…covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms… a useful adjunct to standard clinical trial texts… a reference source to keep within easy reach.» TALANTA The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with clinical trials.

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Fayers Peter M. Randomized Clinical Trials. Design, Practice and Reporting


Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.

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Группа авторов Clinical Trials


This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

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Daniele Martini De Success Probability Estimation with Applications to Clinical Trials


Provides an introduction to the various statistical techniques involved in medical research and drug development with a focus on estimating the success probability of an experiment Success Probability Estimation with Applications to Clinical Trials details the use of success probability estimation in both the planning and analyzing of clinical trials and in widely used statistical tests. Devoted to both statisticians and non-statisticians who are involved in clinical trials, Part I of the book presents new concepts related to success probability estimation and their usefulness in clinical trials, and each section begins with a non-technical explanation of the presented concepts. Part II delves deeper into the techniques for success probability estimation and features applications to both reproducibility probability estimation and conservative sample size estimation. Success Probability Estimation with Applications to Clinical Trials: • Addresses the theoretical and practical aspects of the topic and introduces new and promising techniques in the statistical and pharmaceutical industries Features practical solutions for problems that are often encountered in clinical trials Includes success probability estimation for widely used statistical tests, such as parametric and nonparametric models Focuses on experimental planning, specifically the sample size of clinical trials using phase II results and data for planning phase III trials Introduces statistical concepts related to success probability estimation and their usefulness in clinical trials Success Probability Estimation with Applications to Clinical Trials is an ideal reference for statisticians and biostatisticians in the pharmaceutical industry as well as researchers and practitioners in medical centers who are actively involved in health policy, clinical research, and the design and evaluation of clinical trials.

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Группа авторов Analysis of Clinical Trials Using SAS


Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines.
This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates:


SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST)
SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE)
macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials)


Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.

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David Machin An Introduction to Statistics in Early Phase Trials


All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.

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Chow Shein-Chung Design and Analysis of Clinical Trials. Concepts and Methodologies


Praise for the Second Edition: “…a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

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David Machin Textbook of Clinical Trials


Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: «… very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas.» BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

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Curtis L. Meinert - Wikipedia

From Wikipedia, the free encyclopedia Curtis Lynea Meinert is an American clinical trialist. He is a professor of epidemiology and biostatistics at Johns Hopkins Bloomberg School of Public Health.

Clinical Trials Dictionary (eBook pdf), Curtis L. Meinert

Clinical Trials Dictionary, eBook pdf (pdf eBook) von Curtis L. Meinert bei hugendubel.de als Download für Tolino, eBook-Reader, PC, Tablet und Smartphone.

ClinicalTrials - Curtis L. Meinert - Oxford University Press

Curtis L. Meinert, PhD Monographs in Epidemiology and Biostatistics. The most comprehensive coverage of clinical trial design, conduct, and implementation -written by one of the leading authorities in the field

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Curtis L. Meinert Professorship in Clinical Trials - Named ...

Established in 2005 by Curtis L. Meinert CURTIS L. MEINERT, PhD, is a professor of epidemiology and founding director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health.

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Curtis Meinert, PhD. Professor - Emeritus Departmental Affiliations. Epidemiology (Primary) Division: Clinical Trials and Evidence Synthesis; Center & Institute Affiliations. Johns Hopkins Center for Clinical Trials and Evidence Synthesis ; Contact Information. Bloomberg School of Public Health Room W5010 Baltimore, Maryland 410-955-8198 410-955-0932 cmeiner1@jhu.edu . trialsmeinertsway. Pure ...

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Clinical Trials Handbook | Wiley Online Books

CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials.He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical ...

Wiley: Clinical Trials Handbook: Design and Conduct ...

The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results.

Principles and Practice of Clinical Trials | SpringerLink

Curtis L. Meinert. PDF. Pharmacokinetic and Pharmacodynamic Modeling. Shamir N. Kalaria, Hechuan Wang, Jogarao V. Gobburu. PDF. Power and Sample Size . Elizabeth Garrett-Mayer. PDF. Pragmatic Randomized Trials Using Claims or Electronic Health Record Data. Frank W. Rockhold, Benjamin A. Goldstein. PDF. Principles and Practice of Clinical Trials: Regulatory Requirements in Clinical Trials ...

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Curtis Meinert is a pioneer clinical trialist, involved with the earliest major, multicenter trials (University Group Diabetes Program (UGDP) and the Coronary Drug Project (CDP)).

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Clinical Trials: Design, Conduct and Analysis (Monographs in Epidemiology and Biostatistics, Band 39) | Meinert, Curtis L. | ISBN: 9780195387889 | Kostenloser Versand für alle Bücher mit Versand und Verkauf duch Amazon.

Clinical Trials: Design, Conduct and Analysis - Oxford ...

Curtis L. Meinert Abstract. This book starts with a general discussion of clinical trials. It goes on to describe the activities of a typical study, comparing single center and multicenter trials, reviewing cost factors and assessing the usefulness of clinical trials for the practice of medicine. The book then considers design principles and practices such as sample size estimates and the ...

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Curtis L. Meinert's 347 research works with 8,065 citations and 2,381 reads, including: Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional ...

ClinicalTrials: Design, Conduct and Analysis - Curtis L ...

Curtis L. Meinert, PhD, is a Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health. He was founder of the Center for Clinical Trials...

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Curtis L. Meinert(auth.) A systematic approach to all aspects of designing and conducting clinical trials. The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing ...

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A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions.

Curtis L Meinert — Johns Hopkins University

Fingerprint Dive into the research topics where Curtis L Meinert is active. These topic labels come from the works of this person. Together they form a unique fingerprint. 3 Similar Profiles; Cytomegalovirus Retinitis Medicine & Life Sciences. Clinical Trials Medicine & Life Sciences. Acquired Immunodeficiency Syndrome Medicine & Life Sciences. Alzheimer Disease Medicine & Life Sciences. Eye ...

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CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical ...

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Clinical Trials Handbook: Design and Conduct (English Edition) eBook: Meinert, Curtis L.: Amazon.de: Kindle-Shop Wählen Sie Ihre Cookie-Einstellungen Wir verwenden Cookies und ähnliche Tools, um Ihr Einkaufserlebnis zu verbessern, um unsere Dienste anzubieten, um zu verstehen, wie die Kunden unsere Dienste nutzen, damit wir Verbesserungen vornehmen können, und um Werbung anzuzeigen.

Wiley: Clinical Trials Dictionary: Terminology and Usage ...

Curtis L. Meinert. ISBN: 978-1-118-31526-2. 448 pages. August 2012. Description. A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials . Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and ...

An Insider's Guide to Clinical Trials - Curtis L Meinert ...

An Insider's Guide to Clinical Trials Curtis L Meinert. Provides invaluable information on clinical trials, presented in a clear, approachable way for novice researchers; The book explains how trials are built, how they are run, and how the data is interpreted afterward; Features a glossary of abbreviations used by trialists " Also of Interest. Fibromyalgia. Daniel J. Wallace and J. B. Wallace ...

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Clinical trials handbook : design and conduct / Curtis L. Meinert "Written by an eminent epidemiologist and clinician, this comprehensive book outlines and categorizes the required methodological steps employed in the clinical trial evaluation process. The author appropriately mixes the scientific, logistical, ethical, psychological, behavioral, and administrative... Ausführliche Beschreibung ...

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Curtis L. Meinert, PhD, is a Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health. He was founder of the Center for Clinical Trials and served as its director through September 2005. He was a founding member of the Society for Clinical Trials and was Editor of Controlled Clinical Trials from its inception in 1980 through 1993.

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The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail as Meinert does on such issues as samplesize calculation, stratification and randomization, data systems design, consent form development ...

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CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical ...

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CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials.He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical ...

Design, Conduct, and Analysis of Clinical Trials Course Slides

Design, Conduct, and Analysis of Clinical Trials Course Slides Curtis L Meinert, PhD The Johns Hopkins University School of Hygiene and Public Health Department of Epidemiology Center for Clinical Trials Baltimore Maryland Edition: 2.0 Printing: (2:27pm Sun) 30 Nov 97

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Curtis L. Meinert (Author) › Visit Amazon's Curtis L. Meinert Page. Find all the books, read about the author, and more. See search results for this author. Are you an author? Learn about Author Central. Curtis L. Meinert (Author) 5.0 out of 5 stars 1 rating. ISBN-13: 978-1118295151. ISBN-10: 9781118295151. Why is ISBN important? ISBN. This bar-code number lets you verify that you're getting ...

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The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail as Meinert does on such issues as sample size calculation, stratification and randomization, data systems design, consent form development ...

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Группа авторов Clinical Trials


Learn rigorous statistical methods to ensure valid clinical trials This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First Edition will discover completely new chapters, including: * Contexts for clinical trials * Statistical perspectives * Translational clinical trials * Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the key points. Revised discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge, and updated references are provided to direct readers to the most recent literature. This text distinguishes itself with its accessible and broad coverage of statistical design methods–the crucial building blocks of clinical trials and medical research. Readers learn to conduct clinical trials that produce valid qualitative results backed by rigorous statistical methods.

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Shayne Cox Gad Clinical Trials Handbook


Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

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Группа авторов Management of Data in Clinical Trials


A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of «off-the-shelf» solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

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Simon Wessely Clinical Trials in Psychiatry


At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First Edition: “Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read…it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY "The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications… an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE

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Renee Watson Clinical Trials Explained


What will happen during and after a clinical trial? How will a trial affect my quality of life? What are the benefits and risks of a trial? What does giving consent mean and what will it involve? Will I incur costs during and because of the trial? These are the questions that should be raised every time a health care professional talks through with a patient the pros and cons of entering a clinical trial. Clinical Trials Explained has been designed in consultation with doctors and patients who have taken part in trials, providing an essential and detailed guide to the clinical trials process. It therefore helps both clinicians and patients make well-informed decisions on whether to take part in a clinical trial.

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Alexey Levashov Project Management in Clinical Trials


The book is about both theoretical and practical aspects of Project Management in clinical trials. The audience may find explanation of different phenomena in modern clinical trials, for example, why some approaches in managing trials work and others – do not. In addition to this, the book should serve the purposes of business psychotherapy. The book is saturated with examples from real life and practical tips.

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Dictionary of State Standard Clinical Terminologies of Traditional Chinese Medicine

Salah Abdel-aleem M. The Design and Management of Medical Device Clinical Trials. Strategies and Challenges


Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

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Allan Hackshaw A Concise Guide to Clinical Trials


Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

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Guosheng Yin Clinical Trial Design. Bayesian and Frequentist Adaptive Methods


A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.

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