Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author: Richard Yoonsik Chin,Bruce Y. Lee
Publsiher: Academic Press
Total Pages: 547
Release: 2008
ISBN: 9780123736956
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trial Medicine Book Excerpt:

A concise overview of the essential aspects of clinical research and trial design. Presents the principles and practical details needed to design, conduct, and interpret the results on clinical trials, as well as how to take a drug from initial development to approval stage.

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author: Richard Chin,Bruce Y Lee
Publsiher: Elsevier
Total Pages: 560
Release: 2008-07-25
ISBN: 9780080557939
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trial Medicine Book Excerpt:

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
Publsiher: Springer Nature
Total Pages: 2573
Release: 2022-07-19
ISBN: 3319526367
Category: Mathematics
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trials Book Excerpt:

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing 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 Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) 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 Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine
Author: Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publsiher: John Wiley & Sons
Total Pages: 780
Release: 2007-04-30
ISBN: 9780470093146
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Pharmaceutical Medicine Book Excerpt:

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

Global Clinical Trials Playbook

Global Clinical Trials Playbook
Author: Menghis Bairu,Richard Chin
Publsiher: Academic Press
Total Pages: 320
Release: 2012-06-12
ISBN: 0124158609
Category: Medical
Language: EN, FR, DE, ES & NL

Global Clinical Trials Playbook Book Excerpt:

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Clinical Trials

Clinical Trials
Author: Stuart J. Pocock
Publsiher: John Wiley & Sons
Total Pages: 288
Release: 2013-07-17
ISBN: 1118794109
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical Trials Book Excerpt:

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.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author: John I. Gallin,Frederick P Ognibene
Publsiher: Elsevier
Total Pages: 448
Release: 2011-04-28
ISBN: 9780080489568
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Research Book Excerpt:

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

Success in Academic Surgery Clinical Trials

Success in Academic Surgery  Clinical Trials
Author: Timothy M. Pawlik,Julie A. Sosa
Publsiher: Springer Science & Business Media
Total Pages: 183
Release: 2013-11-04
ISBN: 1447146794
Category: Medical
Language: EN, FR, DE, ES & NL

Success in Academic Surgery Clinical Trials Book Excerpt:

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

Principles and Practice of Multi Agent Systems

Principles and Practice of Multi Agent Systems
Author: Nirmit Desai,Alan Liu,Michael Winikoff
Publsiher: Springer Science & Business Media
Total Pages: 665
Release: 2012-01-09
ISBN: 3642259197
Category: Computers
Language: EN, FR, DE, ES & NL

Principles and Practice of Multi Agent Systems Book Excerpt:

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

Clinical Trials

Clinical Trials
Author: Timothy M. Pawlik,Julie A. Sosa
Publsiher: Springer Nature
Total Pages: 258
Release: 2020-03-10
ISBN: 3030354881
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical Trials Book Excerpt:

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

Clinical Trials in Older Adults

Clinical Trials in Older Adults
Author: Antonio Cherubini,Roberto Bernabei,Luigi Ferrucci,Niccolò Marchionni,Stephanie Studenski,Bruno Vellas
Publsiher: John Wiley & Sons
Total Pages: 280
Release: 2016-01-13
ISBN: 1118323475
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical Trials in Older Adults Book Excerpt:

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

Cancer Research and Clinical Trials in Developing Countries

Cancer Research and Clinical Trials in Developing Countries
Author: Daniela Cristina Stefan
Publsiher: Springer
Total Pages: 218
Release: 2015-12-16
ISBN: 3319184431
Category: Medical
Language: EN, FR, DE, ES & NL

Cancer Research and Clinical Trials in Developing Countries Book Excerpt:

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

Adaptive and Flexible Clinical Trials

Adaptive and Flexible Clinical Trials
Author: Richard Chin
Publsiher: CRC Press
Total Pages: 198
Release: 2016-04-19
ISBN: 143983833X
Category: Mathematics
Language: EN, FR, DE, ES & NL

Adaptive and Flexible Clinical Trials Book Excerpt:

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

Oxford Textbook of Geriatric Medicine

Oxford Textbook of Geriatric Medicine
Author: Jean-Pierre Michel,B. Lynn Beattie,Finbarr C. Martin,Jeremy Walston
Publsiher: Oxford University Press
Total Pages: 1432
Release: 2017-12-01
ISBN: 0191062626
Category: Medical
Language: EN, FR, DE, ES & NL

Oxford Textbook of Geriatric Medicine Book Excerpt:

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

Principles and Practice of Clinical Virology

Principles and Practice of Clinical Virology
Author: Arie J. Zuckerman
Publsiher: John Wiley & Sons
Total Pages: 1042
Release: 2009-03-12
ISBN: 9780470741399
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Virology Book Excerpt:

Principles and Practice of Clinical Virology is the bible for all working in the field of clinical virology – from the trainee to the expert because there’s always something new to learn! As before, the book provides a detailed account of the diagnosis and treatment of virus infections, with a stronger emphasis on clinical expertise and management. Each chapter deals with a single virus or group or viruses and is written by leading international experts in the field. What’s new in this edition ... Showcases the wealth of new knowledge acquired on virus infections and reflects the discovery of newly recognized emerging infections, the improvement or development of new vaccines, and an increasing repertoire of antiviral agents for treatment All chapters have been thoroughly revised and there are a number of new contributors, joining the cadre of internationally-recognized experts Includes a new chapter on vaccinology covering the principles relating to the development and use of vaccines generally, which complements the specific vaccines described in the other chapters The two chapters on nosocomial infections have been enlarged and will be particularly useful for those having to advise on the management of hospital-acquired infections Emphasizes the rapid accumulation of new information in such fields as retroviruses, particularly HIV, SARS, hepatitis C and influenza, including avian influenza

Principles and Practice of Gynecologic Oncology

Principles and Practice of Gynecologic Oncology
Author: Richard R. Barakat,Maurie Markman,Marcus Randall
Publsiher: Lippincott Williams & Wilkins
Total Pages: 1104
Release: 2009
ISBN: 078177845X
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Gynecologic Oncology Book Excerpt:

Providing comprehensive coverage of the biology of gynecologic cancer, the therapeutic modalities available, and the diagnosis and treatment of site-specific malignancies, this edition has 30 percent new contributing authors and new material. A companion Web site offers a fully searchable text.

Behavioral Clinical Trials for Chronic Diseases

Behavioral Clinical Trials for Chronic Diseases
Author: Lynda H. Powell,Kenneth E. Freedland,Peter G. Kaufmann
Publsiher: Springer Nature
Total Pages: 324
Release: 2021
ISBN: 3030393305
Category: Alternative medicine
Language: EN, FR, DE, ES & NL

Behavioral Clinical Trials for Chronic Diseases Book Excerpt:

This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to speak the language of medicine through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Pharmaceutical Suspensions

Pharmaceutical Suspensions
Author: Alok K. Kulshreshtha,Onkar N. Singh,G. Michael Wall
Publsiher: Springer Science & Business Media
Total Pages: 328
Release: 2009-11-05
ISBN: 1441910875
Category: Medical
Language: EN, FR, DE, ES & NL

Pharmaceutical Suspensions Book Excerpt:

The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.

Introductory Medical Statistics 3rd edition

Introductory Medical Statistics  3rd edition
Author: Richard F. Mould
Publsiher: CRC Press
Total Pages: 301
Release: 1998-01-01
ISBN: 1000765075
Category: Mathematics
Language: EN, FR, DE, ES & NL

Introductory Medical Statistics 3rd edition Book Excerpt:

Introductory Medical Statistics, now in its third edition, is an introductory textbook on basic statistical techniques. It is written for physicians, surgeons, radiation oncologists, medical physicists, radiographers, hospital administrators, medical statisticians in training, biochemists, and other professionals allied to medicine. It is suitable

Redesigning the Process for Establishing the Dietary Guidelines for Americans

Redesigning the Process for Establishing the Dietary Guidelines for Americans
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Food and Nutrition Board,Committee to Review the Process to Update the Dietary Guidelines for Americans
Publsiher: National Academies Press
Total Pages: 287
Release: 2017-12-16
ISBN: 030946482X
Category: Medical
Language: EN, FR, DE, ES & NL

Redesigning the Process for Establishing the Dietary Guidelines for Americans Book Excerpt:

What foods should Americans eat to promote their health, and in what amounts? What is the scientific evidence that supports specific recommendations for dietary intake to reduce the risk of multifactorial chronic disease? These questions are critically important because dietary intake has been recognized to have a role as a key determinant of health. As the primary federal source of consistent, evidence-based information on dietary practices for optimal nutrition, the Dietary Guidelines for Americans (DGA) have the promise to empower Americans to make informed decisions about what and how much they eat to improve health and reduce the risk of chronic disease. The adoption and widespread translation of the DGA requires that they be universally viewed as valid, evidence-based, and free of bias and conflicts of interest to the extent possible. However, this has not routinely been the case. A first short report meant to inform the 2020 review cycle explored how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints. This second and final report recommends changes to the DGA process to reduce and manage sources of bias and conflicts of interest, improve timely opportunities for engagement by all interested parties, enhance transparency, and strengthen the science base of the process.