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Safety Data Analysis And Evaluation 2009
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Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies Publisher : ISBN 13 : Total Pages :1468 pages Book Rating :4.F/5 ( download)
Book Synopsis Departments of Transportation, and Housing and Urban Development, and Related Agencies Appropriations for 2009 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies
Download or read book Departments of Transportation, and Housing and Urban Development, and Related Agencies Appropriations for 2009 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies and published by . This book was released on 2008 with total page 1468 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Statistical Methods and Safety Data Analysis and Evaluation by : National Research Council (U.S.). Transportation Research Board
Download or read book Statistical Methods and Safety Data Analysis and Evaluation written by National Research Council (U.S.). Transportation Research Board and published by . This book was released on 2004 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Quantitative Drug Safety and Benefit Risk Evaluation by : William Wang
Download or read book Quantitative Drug Safety and Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-30 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Book Synopsis Medical Product Safety Evaluation by : Jie Chen
Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies Publisher : ISBN 13 : Total Pages :1542 pages Book Rating :4.3/5 ( download)
Book Synopsis Departments of Transportation, and Housing and Urban Development, and Related Agencies Appropriations for 2014 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies
Download or read book Departments of Transportation, and Housing and Urban Development, and Related Agencies Appropriations for 2014 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies and published by . This book was released on 2013 with total page 1542 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang
Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve
Book Synopsis A Picture is Worth a Thousand Tables by : Andreas Krause
Download or read book A Picture is Worth a Thousand Tables written by Andreas Krause and published by Springer Science & Business Media. This book was released on 2012-12-12 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is devoted to the graphics of patient data: good graphs enabling straight¬forward and intuitive interpretation, efficient creation, and straightforward interpretation. We focus on easy access to graphics of patient data: the intention is to show a large variety of graphs for different phases of drug development, together with a description of what the graph shows, what type of data it uses, and what options there are. The main aim is to provide inspiration in form of a “graphics cookbook.” Many graphs provide creative ideas about what can be done. The book is not intended to be technical. It introduces general principles of good visualization to make readers understand the concepts, but the main focus is on the creativity and usefulness: readers are enabled to browse through the book to get ideas of how their own data can be analyzed graphically. For additional information visit Editor’s companion website: http://www.elmo.ch/doc/life-science-graphics/
Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace
Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-21 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.
Book Synopsis Proceedings of the Sixth International Conference of Transportation Research Group of India by : Lelitha Devi
Download or read book Proceedings of the Sixth International Conference of Transportation Research Group of India written by Lelitha Devi and published by Springer Nature. This book was released on 2022-09-28 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book comprises the proceedings of the Sixth International Conference of Transportation Research Group of India (CTRG2021) focusing on emerging opportunities and challenges in the field of transportation of people and freight. The contents of the volume include characterization of conventional and innovative pavement materials, operational effects of road geometry, user impact of multimodal transport projects, spatial analysis of travel patterns, socio-economic impacts of transport projects, analysis of transportation policy and planning for safety and security, technology enabled models of mobility services, etc. This book will be beneficial to researchers, educators, practitioners and policy makers alike.
Book Synopsis Mann's Pharmacovigilance by : Elizabeth B. Andrews
Download or read book Mann's Pharmacovigilance written by Elizabeth B. Andrews and published by John Wiley & Sons. This book was released on 2014-06-23 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Download or read book Vaccinology written by W. John W. Morrow and published by John Wiley & Sons. This book was released on 2012-09-04 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering all aspects of vaccine research and development in one volume, this authoritative resource takes a comprehensive and systematic approach to the science of vaccinology focusing not only on basic science, but also on the many stages required to commercialize and navigate the regulatory requirements for human application, both in the United States and Europe. Reviews in detail the process of designing a vaccine, from the initial stages of antigen discovery to human application Includes evaluation of vaccine efficacy and safety Details clinical trial design, including regulatory requirements Discusses the emerging field of active cellular immunotherapy Vaccinology: Principles and Practice provides an invaluable resource for clinicians, scientific and medical researchers, lecturers and postdoctoral fellows working in the field of vaccines.
Book Synopsis Non-Motorized Transport Integration into Urban Transport Planning in Africa by : Winnie V. Mitullah
Download or read book Non-Motorized Transport Integration into Urban Transport Planning in Africa written by Winnie V. Mitullah and published by Taylor & Francis. This book was released on 2017-07-14 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: What challenges do pedestrians and cyclists face in cities of the developing world? What opportunities do these cities have to provide for walking and cycling? Based on in-depth research conducted in Cape Town (South Africa), Dar es Salaam (Tanzania) and Nairobi (Kenya), this book explores these questions by presenting work on walking and cycling travel behaviour, the status of road safety in these cities, as well as an analysis of the infrastructure for walking and cycling, and the workings of the institutions responsible for planning for these modes. The book also presents case studies relating to particular opportunities and challenges, such as the development and evaluation of ‘walking bus’ interventions, and the opportunities micro-simulation of pedestrian interventions offers within a data-scarce environment. Non-motorized Transport Integration into Urban Transport Planning in Africa demonstrates that transport and urban planning remains situated in a logic of automobile-dependent transport planning and global city development. This logic of practice does not pay adequate attention to walking and cycling. It argues that a significant shift in both policy as well as political commitment is needed so as to prioritize walking and cycling as strategies for sustainable transport policy in urban Africa. This book will be a key text for practitioners and policy makers working in planning, transport policy and urban development in Africa, as well as students and scholars of African studies, development studies, urban geography, transport studies and sustainable development.
Book Synopsis Highway Safety Analytics and Modeling by : Dominique Lord
Download or read book Highway Safety Analytics and Modeling written by Dominique Lord and published by Elsevier. This book was released on 2021-02-27 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highway Safety Analytics and Modeling comprehensively covers the key elements needed to make effective transportation engineering and policy decisions based on highway safety data analysis in a single. reference. The book includes all aspects of the decision-making process, from collecting and assembling data to developing models and evaluating analysis results. It discusses the challenges of working with crash and naturalistic data, identifies problems and proposes well-researched methods to solve them. Finally, the book examines the nuances associated with safety data analysis and shows how to best use the information to develop countermeasures, policies, and programs to reduce the frequency and severity of traffic crashes. - Complements the Highway Safety Manual by the American Association of State Highway and Transportation Officials - Provides examples and case studies for most models and methods - Includes learning aids such as online data, examples and solutions to problems
Book Synopsis Quantitative Methods in Pharmaceutical Research and Development by : Olga V. Marchenko
Download or read book Quantitative Methods in Pharmaceutical Research and Development written by Olga V. Marchenko and published by Springer Nature. This book was released on 2020-09-24 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and marketing. Chapters bring together the theories and applications of various disciplines, allowing readers to learn more about quantitative fields, and to better recognize the differences between them. Because it provides a thorough overview, this will serve as a self-contained resource for readers interested in the pharmaceutical industry, and the quantitative methods that serve as its foundation. Specific disciplines covered include: Biostatistics Pharmacometrics Genomics Bioinformatics Pharmacoepidemiology Commercial analytics Operational analytics Quantitative Methods in Pharmaceutical Research and Development is ideal for undergraduate students interested in learning about real-world applications of quantitative methods, and the potential career options open to them. It will also be of interest to experts working in these areas.
Book Synopsis Data and Safety Monitoring Committees in Clinical Trials, Second Edition by : Jay Herson
Download or read book Data and Safety Monitoring Committees in Clinical Trials, Second Edition written by Jay Herson and published by CRC Press. This book was released on 2016-12-19 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?
Book Synopsis Evaluation of Safety and Environmental Metrics for Potential Application at Chemical Agent Disposal Facilities by : National Research Council
Download or read book Evaluation of Safety and Environmental Metrics for Potential Application at Chemical Agent Disposal Facilities written by National Research Council and published by National Academies Press. This book was released on 2009-06-15 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: By the end of 2009, more than 60 percent of the global chemical weapons stockpile declared by signatories to the Chemical Weapons Convention will have been destroyed, and of the 184 signatories, only three countries will possess chemical weapons-the United States, Russia, and Libya. In the United States, destruction of the chemical weapons stockpile began in 1990, when Congress mandated that the Army and its contractors destroy the stockpile while ensuring maximum safety for workers, the public, and the environment. The destruction program has proceeded without serious exposure of any worker or member of the public to chemical agents, and risk to the public from a storage incident involving the aging stockpile has been reduced by more than 90 percent from what it was at the time destruction began on Johnston Island and in the continental United States. At this time, safety at chemical agent disposal facilities is far better than the national average for all industries. Even so, the Army and its contractors are desirous of further improvement. To this end, the Chemical Materials Agency (CMA) asked the NRC to assist by reviewing CMA's existing safety and environmental metrics and making recommendations on which additional metrics might be developed to further improve its safety and environmental programs.
Book Synopsis Vaccinophobia and Vaccine Controversies of the 21st Century by : Archana Chatterjee
Download or read book Vaccinophobia and Vaccine Controversies of the 21st Century written by Archana Chatterjee and published by Springer Science & Business Media. This book was released on 2013-06-25 with total page 503 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccinophobia and Vaccine Controversies of the 21st Century Archana Chatterjee, editor Once hailed as a medical miracle, vaccination has come under attack from multiple fronts, including occasionally from within medicine. And while the rates of adverse reactions remain low, suggestions that vaccines can cause serious illness (and even death) are inspiring parents to refuse routine immunizations for their children--ironically, exposing them and others to potentially serious illness. Vaccinophobia and Vaccine Controversies of the 21st Century explains clearly how this state of affairs came into being, why it persists, and how healthcare professionals can best respond. Current findings review answers to bedrock questions about known adverse events, what vaccine additives are used for, and real and perceived risks involved in immunization. Perspectives representing pediatricians, family practitioners, nurses, parents, pharmacy professionals, the CDC, and the public health community help the reader sort out legitimate from irrational concerns. In-depth analyses discuss the possibility of links with asthma, cancer, Guillain-Barre syndrome, SIDS, and, of course, autism. Included in the coverage: Communicating vaccine risks and benefits The vaccine misinformation landscape in family medicine Perceived risks from live viral vaccines The media's role in vaccine misinformation Autoimmunity, allergies, asthma, and a relationship to vaccines Vaccines and autism: the controversy that won't go away The conundrums described here are pertinent to practitioners in pediatrics, family medicine, primary care, and nursing to help families with informed decision making. In addition, Vaccinophobia and Vaccine Controversies of the 21st Century should be read by trainees and researchers in child development and maternal and child health as the book's issues will have an impact on future generations of children and their families.
