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 347 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.
Download or read book Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-31 with total page 382 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"--
Download or read book The Cambridge Handbook of Health Research Regulation written by Graeme Laurie and published by . This book was released on 2021-06-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
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.
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 216 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 rele
Download or read book Quantitative Microbial Risk Assessment written by Charles N. Haas and published by John Wiley & Sons. This book was released on 2014-07-08 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides the latest QMRA methodologies to determine infection risk cause by either accidental microbial infections or deliberate infections caused by terrorism • Reviews the latest methodologies to quantify at every step of the microbial exposure pathways, from the first release of a pathogen to the actual human infection • Provides techniques on how to gather information, on how each microorganism moves through the environment, how to determine their survival rates on various media, and how people are exposed to the microorganism • Explains how QMRA can be used as a tool to measure the impact of interventions and identify the best policies and practices to protect public health and safety • Includes new information on genetic methods • Techniques use to develop risk models for drinking water, groundwater, recreational water, food and pathogens in the indoor environment
Download or read book Benefit Risk Assessment of Medicines written by James Leong and published by Adis. This book was released on 2016-10-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.
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.
Download or read book Risk Assessment in the Federal Government written by National Research Council and published by National Academies Press. This book was released on 1983-02-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Download or read book Capturing Social and Behavioral Domains and Measures in Electronic Health Records written by Institute of Medicine and published by National Academies Press. This book was released on 2015-01-08 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Determinants of health - like physical activity levels and living conditions - have traditionally been the concern of public health and have not been linked closely to clinical practice. However, if standardized social and behavioral data can be incorporated into patient electronic health records (EHRs), those data can provide crucial information about factors that influence health and the effectiveness of treatment. Such information is useful for diagnosis, treatment choices, policy, health care system design, and innovations to improve health outcomes and reduce health care costs. Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 identifies domains and measures that capture the social determinants of health to inform the development of recommendations for the meaningful use of EHRs. This report is the second part of a two-part study. The Phase 1 report identified 17 domains for inclusion in EHRs. This report pinpoints 12 measures related to 11 of the initial domains and considers the implications of incorporating them into all EHRs. This book includes three chapters from the Phase 1 report in addition to the new Phase 2 material. Standardized use of EHRs that include social and behavioral domains could provide better patient care, improve population health, and enable more informative research. The recommendations of Capturing Social and Behavioral Domains and Measures in Electronic Health Records: Phase 2 will provide valuable information on which to base problem identification, clinical diagnoses, patient treatment, outcomes assessment, and population health measurement.
Download or read book Challenges for the FDA written by Institute of Medicine and published by National Academies Press. This book was released on 2007-10-02 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
Download or read book Occupational Health and Safety in the Care and Use of Nonhuman Primates written by National Research Council and published by National Academies Press. This book was released on 2003-06-13 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.
Download or read book Evidence Based Pharmacovigilance written by Andrew Bate and published by Humana. This book was released on 2018-10-26 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.
Download or read book Practical Approaches to Risk Minimisation for Medicinal Products written by World Health Organization and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
