Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Characterizing And Communicating Uncertainty In The Assessment Of Benefits And Risks Of Pharmaceutical Products
Download Characterizing And Communicating Uncertainty In The Assessment Of Benefits And Risks Of Pharmaceutical Products full books in PDF, epub, and Kindle. Read online Characterizing And Communicating Uncertainty In The Assessment Of Benefits And Risks Of Pharmaceutical Products ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by : Institute of Medicine
Download or read book Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by Institute of Medicine and published by National Academies Press. This book was released on 2014-12-19 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.
Book Synopsis Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by :
Download or read book Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by and published by . This book was released on 2014 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: On February 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop as the first of a two-part series to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, as well as their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. This brief summary of the workshop provides highlights from the presentations and discussions.
Book Synopsis Understanding the Benefits and Risks of Pharmaceuticals by : Institute of Medicine
Download or read book Understanding the Benefits and Risks of Pharmaceuticals written by Institute of Medicine and published by National Academies Press. This book was released on 2007-09-14 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.
Book Synopsis Benefit-Risk Assessment in Pharmaceutical Research and Development by : Andreas Sashegyi
Download or read book Benefit-Risk Assessment in Pharmaceutical Research and Development written by Andreas Sashegyi and published by CRC Press. This book was released on 2013-11-27 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.
Book Synopsis Benefit-Risk Assessment Methods in Medical Product Development by : Qi Jiang
Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
Book Synopsis Multi-Criteria Decision Analysis to Support Healthcare Decisions by : Kevin Marsh
Download or read book Multi-Criteria Decision Analysis to Support Healthcare Decisions written by Kevin Marsh and published by Springer. This book was released on 2017-04-18 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Representing the first collection on the topic, this book builds from foundations to case studies, to future prospects, providing the reader with a rich and comprehensive understanding of the use of multi-criteria decision analysis (MCDA) in healthcare. The first section of the collection presents the foundations of MCDA as it is applied to healthcare decisions, providing guidance on the ethical and theoretical underpinnings of MCDA and how to select MCDA methods appropriate to different decision settings. Section two comprises a collection of case studies spanning the decision continuum, including portfolio development, benefit–risk assessment, health technology assessment, priority setting, resource optimisation, clinical practice and shared decision making. Section three explores future directions in the application of MCDA to healthcare and identifies opportunities for further research to support these.
Book Synopsis The Science of Science Communication III by : National Academy of Sciences
Download or read book The Science of Science Communication III written by National Academy of Sciences and published by National Academies Press. This book was released on 2018-06-01 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful scientists must be effective communicators within their professions. Without those skills, they could not write papers and funding proposals, give talks and field questions, or teach classes and mentor students. However, communicating with audiences outside their profession - people who may not share scientists' interests, technical background, cultural assumptions, and modes of expression - presents different challenges and requires additional skills. Communication about science in political or social settings differs from discourse within a scientific discipline. Not only are scientists just one of many stakeholders vying for access to the public agenda, but the political debates surrounding science and its applications may sometimes confront scientists with unfamiliar and uncomfortable discussions involving religious values, partisan interests, and even the trustworthiness of science. The Science of Science Communication III: Inspiring Novel Collaborations and Building Capacity summarizes the presentations and discussions from a Sackler Colloquium convened in November 2017. This event used Communicating Science Effectively as a framework for examining how one might apply its lessons to research and practice. It considered opportunities for creating and applying the science along with the barriers to doing so, such as the incentive systems in academic institutions and the perils of communicating science in polarized environments. Special attention was given to the organization and infrastructure necessary for building capacity in science communication.
Book Synopsis Insights in Regulatory Science: 2021 by : Bruno Sepodes
Download or read book Insights in Regulatory Science: 2021 written by Bruno Sepodes and published by Frontiers Media SA. This book was released on 2022-11-04 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030968224X Total Pages :273 pages Book Rating :4.3/5 (96 download)
Book Synopsis Framework for Equitable Allocation of COVID-19 Vaccine by : National Academies of Sciences, Engineering, and Medicine
Download or read book Framework for Equitable Allocation of COVID-19 Vaccine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-11-30 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309489172 Total Pages :211 pages Book Rating :4.3/5 (94 download)
Book Synopsis Exploring Medical and Public Health Preparedness for a Nuclear Incident by : National Academies of Sciences, Engineering, and Medicine
Download or read book Exploring Medical and Public Health Preparedness for a Nuclear Incident written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-05 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Academies of Sciences, Engineering, and Medicine held a workshop on August 22â€"23, 2018, in Washington, DC, to explore medical and public health preparedness for a nuclear incident. The event brought together experts from government, nongovernmental organizations, academia, and the private sector to explore current assumptions behind the status of medical and public health preparedness for a nuclear incident, examine potential changes in these assumptions in light of increasing concerns about the use of nuclear warfare, and discuss challenges and opportunities for capacity building in the current threat environment. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis The Human Microbiome, Diet, and Health by : Food Forum
Download or read book The Human Microbiome, Diet, and Health written by Food Forum and published by National Academies Press. This book was released on 2013-02-27 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food Forum convened a public workshop on February 22-23, 2012, to explore current and emerging knowledge of the human microbiome, its role in human health, its interaction with the diet, and the translation of new research findings into tools and products that improve the nutritional quality of the food supply. The Human Microbiome, Diet, and Health: Workshop Summary summarizes the presentations and discussions that took place during the workshop. Over the two day workshop, several themes covered included: The microbiome is integral to human physiology, health, and disease. The microbiome is arguably the most intimate connection that humans have with their external environment, mostly through diet. Given the emerging nature of research on the microbiome, some important methodology issues might still have to be resolved with respect to undersampling and a lack of causal and mechanistic studies. Dietary interventions intended to have an impact on host biology via their impact on the microbiome are being developed, and the market for these products is seeing tremendous success. However, the current regulatory framework poses challenges to industry interest and investment.
Book Synopsis Science and Decisions by : National Research Council
Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
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.
Book Synopsis Representing Scientific Knowledge by : Chaomei Chen
Download or read book Representing Scientific Knowledge written by Chaomei Chen and published by Springer. This book was released on 2017-11-25 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is written for anyone who is interested in how a field of research evolves and the fundamental role of understanding uncertainties involved in different levels of analysis, ranging from macroscopic views to meso- and microscopic ones. We introduce a series of computational and visual analytic techniques, from research areas such as text mining, deep learning, information visualization and science mapping, such that readers can apply these tools to the study of a subject matter of their choice. In addition, we set the diverse set of methods in an integrative context, that draws upon insights from philosophical, sociological, and evolutionary theories of what drives the advances of science, such that the readers of the book can guide their own research with their enriched theoretical foundations. Scientific knowledge is complex. A subject matter is typically built on its own set of concepts, theories, methodologies and findings, discovered by generations of researchers and practitioners. Scientific knowledge, as known to the scientific community as a whole, experiences constant changes. Some changes are long-lasting, whereas others may be short lived. How can we keep abreast of the state of the art as science advances? How can we effectively and precisely convey the status of the current science to the general public as well as scientists across different disciplines? The study of scientific knowledge in general has been overwhelmingly focused on scientific knowledge per se. In contrast, the status of scientific knowledge at various levels of granularity has been largely overlooked. This book aims to highlight the role of uncertainties, in developing a better understanding of the status of scientific knowledge at a particular time, and how its status evolves over the course of the development of research. Furthermore, we demonstrate how the knowledge of the types of uncertainties associated with scientific claims serves as an integral and critical part of our domain expertise.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309377552 Total Pages :169 pages Book Rating :4.3/5 (93 download)
Book Synopsis Effective Chemistry Communication in Informal Environments by : National Academies of Sciences, Engineering, and Medicine
Download or read book Effective Chemistry Communication in Informal Environments written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-08-19 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemistry plays a critical role in daily life, impacting areas such as medicine and health, consumer products, energy production, the ecosystem, and many other areas. Communicating about chemistry in informal environments has the potential to raise public interest and understanding of chemistry around the world. However, the chemistry community lacks a cohesive, evidence-based guide for designing effective communication activities. This report is organized into two sections. Part A: The Evidence Base for Enhanced Communication summarizes evidence from communications, informal learning, and chemistry education on effective practices to communicate with and engage publics outside of the classroom; presents a framework for the design of chemistry communication activities; and identifies key areas for future research. Part B: Communicating Chemistry: A Framework for Sharing Science is a practical guide intended for any chemists to use in the design, implementation, and evaluation of their public communication efforts.
Book Synopsis Translational Toxicology by : Claude L. Hughes
Download or read book Translational Toxicology written by Claude L. Hughes and published by Humana Press. This book was released on 2016-03-23 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bringing together a distinguished interdisciplinary team of contributors, this volume provides a comprehensive exploration of translational toxicology—a systematic approach to developing therapeutic interventions that can protect against, mitigate, or reverse the effects of exposures. In particular, the book addresses modes of action and biomarkers, developmental risks of exposures, and potential translational toxicology therapeutics. The result is a compelling application of developmental toxicology in a new therapeutic discipline that is destined to become part of standard medical practice. Translational Toxicology: Defining a New Therapeutic Discipline is an essential text for regulatory authorities, scientists, and physicians who are concerned with environmental exposures, public health, nutrition, and pharmaceutical research and development. Basic science, epidemiological, and clinical investigators will also find this book a significant resource.
Author :The Expert Panel on Effectiveness of Health Product Risk Communication Publisher :Council of CanadianAcademies ISBN 13 :1926522133 Total Pages :212 pages Book Rating :4.9/5 (265 download)
Book Synopsis Health Product Risk Communication: Is the Message Getting Through? by : The Expert Panel on Effectiveness of Health Product Risk Communication
Download or read book Health Product Risk Communication: Is the Message Getting Through? written by The Expert Panel on Effectiveness of Health Product Risk Communication and published by Council of CanadianAcademies. This book was released on 2015-06-09 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communicating about risk cannot be reduced to a simple formula. There are a range of potential hazards that can pose risks to health, and these risks can vary in severity, certainty, probability, and complexity.
