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Author :
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (14 download)
Download or read book Clinical Drug Investigation written by and published by . This book was released on with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : A. Cohen
Publisher : Springer Science & Business Media
ISBN 13 : 940158463X
Total Pages : 205 pages
Book Rating : 4.4/5 (15 download)
Download or read book A Guide to Clinical Drug Research written by A. Cohen and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author : Alison Blenkinsopp
Publisher : John Wiley & Sons
ISBN 13 : 111859844X
Total Pages : 394 pages
Book Rating : 4.1/5 (185 download)
Download or read book Symptoms in the Pharmacy written by Alison Blenkinsopp and published by John Wiley & Sons. This book was released on 2013-03-27 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and evidence-based guide for student, pre-registration and qualified pharmacists Symptoms in the Pharmacy is an indispensable guide to the management of common symptoms seen in the pharmacy. With advice from an author team that includes both pharmacists and GPs, the book covers ailments which will be encountered in the pharmacy on a daily basis. Now in its sixth edition Symptoms in the Pharmacy has been fully revised to reflect the latest evidence and availability of new medicines. There are new sections and case studies for 'POM' to 'P' switches including chloramphenicol, sumatriptan, diclofenac, naproxen and amorolfine. This edition features colour photographs of skin conditions for the first time enabling the differentiation and diagnosis of common complaints. The public health and illness prevention content have been expanded to support this increasingly important aspect of the pharmacist’s work. The book is designed for quick and easy reference with separate chapters for each ailment. Each chapter incorporates a decision making framework in which the information necessary for treatment and suggestions on ‘when to refer’ is distilled into helpful summary boxes. At the end of each chapter there are example case studies providing the view of pharmacists, doctors and patients for most conditions covered. These easy-to-follow- chapters can be read cover to cover or turned to for quick reference. This useful guide should be kept close at hand for frequent consultation.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Author : Kalman Dubov
Publisher : Kalman Dubov
ISBN 13 :
Total Pages : pages
Book Rating : 4./5 ( download)
Download or read book Clinical Investigations - Drugs written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: These two modules present detailed training on conducting clinical investigations on drugs. The process to gain marketing approval from the US Food & Drug Administration requires extensive and detailed interaction with Agency officials, from inception through the different study trial phases. The requirements for the study sponsor and the principal investigator are different, but both must comply with the FDA's lengthy and detailed regulations and guidance documents. These modules are designed to assist the study sponsor and investigator to comply with the FDA so that the study is conducted with minimal difficulty. The module begins with a discussion regarding the differences between medical care to that of a clinical investigation. The module continues with a regulatory definition of a drug, the general responsibilities of a clinical investigator, through study designs, to include documentation requirements for both the study sponsor and the investigator. Module B continues the training detailing how a protocol is submitted to the FDA, through the FDA audit process. These two modules will enable the study sponsor and clinical investigator to have detailed background knowledge of the nature of a drug's clinical investigation. As in all matters, knowledge of a subject is critical in understanding how the process works so that compliance is not a matter of guesswork.
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309046289
Total Pages : 337 pages
Book Rating : 4.3/5 (9 download)
Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.
Author : Gary M. Matoren
Publisher : CRC Press
ISBN 13 : 1000148718
Total Pages : 584 pages
Book Rating : 4.0/5 (1 download)
Download or read book The Clinical Research Process in the Pharmaceutical Industry written by Gary M. Matoren and published by CRC Press. This book was released on 2020-08-18 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.
Author : David Ginsberg
Publisher :
ISBN 13 :
Total Pages : 324 pages
Book Rating : 4.3/5 (555 download)
Download or read book The Investigator's Guide to Clinical Research written by David Ginsberg and published by . This book was released on 2002 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Investigator's Guide to Clinical Research is a step-by-step manual filled with tips, instructions and insights for investigators - novice and experienced - and health professionals involved in conducting clinical research. Along with updated sections, charts and statistics, the 3rd edition includes a detailed look at investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. A new appendix includes valuable lists of company contacts and additional resources. Developed in accordance with the essentials and standards of the ACCME. Exam is provided online. Topics include...An overview of the clinical development process; A review of regulatory requirements; How to set up and manage a research center; How to effectively and efficiently conduct clinical trials and How to identify and secure clinical grant opportunities.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : Cohen
Publisher :
ISBN 13 : 9788184893106
Total Pages : 222 pages
Book Rating : 4.8/5 (931 download)
Download or read book A Guide To Clinical Drug Research, 2E written by Cohen and published by . This book was released on 2009-08-01 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : SK Gupta
Publisher : JAYPEE BROTHERS PUBLISHERS
ISBN 13 : 9350900335
Total Pages : 665 pages
Book Rating : 4.3/5 (59 download)
Download or read book Drug Discovery and Clinical Research written by SK Gupta and published by JAYPEE BROTHERS PUBLISHERS. This book was released on with total page 665 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 542 pages
Book Rating : 4.:/5 (44 download)
Download or read book Drug Investigation written by and published by . This book was released on 1994 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt:
