Download or read book Guideline for the Format and Content of the Clinical and Statistical Sections of an Application written by and published by . This book was released on 1988 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guideline for the Format and Content of the Clinical and Statistical Sections of an Application written by Center for Drug Evaluation and Research (U.S.) and published by . This book was released on 1988 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guideline for the Format and Content of the Clinical and Statistical Sections of an Application written by Center for Drug Evaluation and Research (États-Unis). and published by . This book was released on 1988 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications written by United States. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research and published by . This book was released on 1988 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Draft Guideline for the Format and Content of Clinical Data Section and Statistical Section of a New Drug Application written by Robert Temple and published by . This book was released on 1986 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guideline for the Format and Content of the Clinical Data Section of an Application Docket No 85D 0467 Draft written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1986 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Statistics In the Pharmaceutical Industry 3rd Edition written by Charles Ralph Buncher and published by CRC Press. This book was released on 1993-11-17 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.

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.

Download or read book Biostatistics in Clinical Trials written by Carol K. Redmond and published by John Wiley & Sons. This book was released on 2001-04-25 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

Download or read book Statistics In the Pharmaceutical Industry written by C. Ralph Buncher and published by CRC Press. This book was released on 2019-03-07 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1998-04 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guideline on Formatting Assembling and Submitting New Drug and Antibiotic Applications written by and published by . This book was released on 1987 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Translational Orthopedics written by Jeffrey A. Bakal and published by Elsevier. This book was released on 2024-04-26 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in translational orthopedics, and know what is needed in collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in translational orthopedics, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every Medical Researcher or Orthopedist who has ever had a good clinical idea but not the knowledge of how to test it. Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within orthopedics Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation Details discussions of the critical appraisal of published studies in translational orthopedics, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care

Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2013-09-30 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Drug Development written by Charles E. Hamner and published by CRC Press. This book was released on 2019-06-12 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development.

Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Learning. This book was released on 2011 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic­ ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, discuss how quality planning, safety training and data standardization result in significant cost, time and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides the definitive guide to drug safety data analysis and reporting. Key features include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports Pragmatic tipsàand mistakes to avoid Simple explanations of what safety data are collected, and what the data mean Practical approaches to determining a drug effect and understanding its clinical significance Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical Examples of user-friendly data displays that enhance safety signal identification Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting Relevant material for the required training of drug safety/pharmacovigilance professionals SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Download or read book Principles of Gender Specific Medicine written by and published by Elsevier. This book was released on 2004-07-02 with total page 1331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Gender-Specific Medicine examines how normal human biology differs between men and women and how the diagnosis and treatment of disease differs as a function of gender. This revealing research covers various conditions that predominantly occur in men, and as well conditions that predominantly occur in women. Among the subjects covered are cardiovascular disease, mood disorders, the immune system, lung cancer as a consequence of smoking, osteoporosis, diabetes, obesity, and infectious diseases. * Gathers important information in the field of gender-based biology and clinical medicine, proving that a patient's sex is increasingly important in preventing illness, making an accurate diagnosis, and choosing safe and effective treatment of disease * Addresses gender-specific areas ranging from organ transplantation, gall bladder and biliary diseases, to the epidemiology of osteoporosis and fractures in men and women * Many chapters present questions about future directions of investigations