Exposure-Response Modeling

Exposure-Response Modeling PDF

Author: Jixian Wang

Publisher: CRC Press

Published: 2015-07-17

Total Pages: 348

ISBN-13: 146657321X

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Discover the Latest Statistical Approaches for Modeling Exposure-Response RelationshipsWritten by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacody

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Assessment of Exposure-Response Functions for Rocket-Emission Toxicants

Assessment of Exposure-Response Functions for Rocket-Emission Toxicants PDF

Author: National Research Council

Publisher: National Academies Press

Published: 1998-07-24

Total Pages: 226

ISBN-13: 0309173841

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The U.S. Air Force is developing a model to assist commanders in determining when it is safe to launch rocket vehicles. The model estimates the possible number and types of adverse health effects for people who might be exposed to the ground cloud created by rocket exhaust during a normal launch or during an aborted launch that results in a rocket being destroyed near the ground. Assessment of Exposure-Response Functions for Rocket-Emmission Toxicants evaluates the model and the data used for three rocket emission toxicants: hydrogen chloride, nitrogen dioxide, and nitric acid.

A Framework to Guide Selection of Chemical Alternatives

A Framework to Guide Selection of Chemical Alternatives PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2014-10-29

Total Pages: 280

ISBN-13: 0309310164

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Historically, regulations governing chemical use have often focused on widely used chemicals and acute human health effects of exposure to them, as well as their potential to cause cancer and other adverse health effects. As scientific knowledge has expanded there has been an increased awareness of the mechanisms through which chemicals may exert harmful effects on human health, as well as their effects on other species and ecosystems. Identification of high-priority chemicals and other chemicals of concern has prompted a growing number of state and local governments, as well as major companies, to take steps beyond existing hazardous chemical federal legislation. Interest in approaches and policies that ensure that any new substances substituted for chemicals of concern are assessed as carefully and thoroughly as possible has also burgeoned. The overarching goal of these approaches is to avoid regrettable substitutions, which occur when a toxic chemical is replaced by another chemical that later proved unsuitable because of persistence, bioaccumulation, toxicity, or other concerns. Chemical alternative assessments are tools designed to facilitate consideration of these factors to assist stakeholders in identifying chemicals that may have the greatest likelihood of harm to human and ecological health, and to provide guidance on how the industry may develop and adopt safer alternatives. A Framework to Guide Selection of Chemical Alternatives develops and demonstrates a decision framework for evaluating potentially safer substitute chemicals as primarily determined by human health and ecological risks. This new framework is informed by previous efforts by regulatory agencies, academic institutions, and others to develop alternative assessment frameworks that could be operationalized. In addition to hazard assessments, the framework incorporates steps for life-cycle thinking - which considers possible impacts of a chemical at all stages including production, use, and disposal - as well as steps for performance and economic assessments. The report also highlights how modern information sources such as computational modeling can supplement traditional toxicology data in the assessment process. This new framework allows the evaluation of the full range of benefits and shortcomings of substitutes, and examination of tradeoffs between these risks and factors such as product functionality, product efficacy, process safety, and resource use. Through case studies, this report demonstrates how different users in contrasting decision contexts with diverse priorities can apply the framework. This report will be an essential resource to the chemical industry, environmentalists, ecologists, and state and local governments.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide PDF

Author: Agency for Health Care Research and Quality (U.S.)

Publisher: Government Printing Office

Published: 2013-02-21

Total Pages: 204

ISBN-13: 1587634236

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This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Holland-Frei Cancer Medicine

Holland-Frei Cancer Medicine PDF

Author: Robert C. Bast, Jr.

Publisher: John Wiley & Sons

Published: 2017-03-10

Total Pages: 2008

ISBN-13: 111900084X

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Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates

Estimating the Public Health Benefits of Proposed Air Pollution Regulations

Estimating the Public Health Benefits of Proposed Air Pollution Regulations PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2002-10-30

Total Pages: 187

ISBN-13: 0309169011

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EPA estimates that thousands of premature deaths and cases of illnesses may be avoided by reducing air pollution. At the request of Congress, this report reviews the scientific basis of EPA's methods used in estimating the public health benefits from its air pollution regulations.

Handbook of Exposure Therapies

Handbook of Exposure Therapies PDF

Author: David C.S. Richard

Publisher: Elsevier

Published: 2011-10-11

Total Pages: 464

ISBN-13: 0080467814

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Exposure Therapy refers to any clinical intervention in which a client directly confronts a source of fear. Since high levels of anxiety can not be maintained indefinitely, repeated exposure leads to decreased anxiety. This type of treatment is effective with phobias, post traumatic stress disorder, obsessive compulsive disorders, panic, generalized anxiety, and several other disorders. It's also been found to be effective in helping to treat substance abuse. Although exposure-based treatments have been extensively researched and reported in the literature, there is no single comprehensive treatment of exposure therapies. Writings tend to be limited to larger pieces on treating specific disorders or types of patients. A comprehensive book on the use of these treatments across patient disorders will be of great use to practitioners. The book is divided into three sections: Foundation, Applications, and Issues. Foundation chapters considers theoretical and assessment issues. Applications chapters will discuss research literature on each disorder having been proven to be successfully treated with exposure therapy. Issue chapters will discuss liability issues, false memory syndrome, and the use of computers and virtual reality in exposure therapy. *Covers the broad range of exposure therapies in one comprehensive source *Provides an integrated look at exposure therapy across a variety of disorders *Each such chapter will include a case study *Blends literature review and practice guidelines

Health Risks from Exposure to Low Levels of Ionizing Radiation

Health Risks from Exposure to Low Levels of Ionizing Radiation PDF

Author: Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation

Publisher: National Academies Press

Published: 2006-03-23

Total Pages: 422

ISBN-13: 0309133343

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This book is the seventh in a series of titles from the National Research Council that addresses the effects of exposure to low dose LET (Linear Energy Transfer) ionizing radiation and human health. Updating information previously presented in the 1990 publication, Health Effects of Exposure to Low Levels of Ionizing Radiation: BEIR V, this book draws upon new data in both epidemiologic and experimental research. Ionizing radiation arises from both natural and man-made sources and at very high doses can produce damaging effects in human tissue that can be evident within days after exposure. However, it is the low-dose exposures that are the focus of this book. So-called “late” effects, such as cancer, are produced many years after the initial exposure. This book is among the first of its kind to include detailed risk estimates for cancer incidence in addition to cancer mortality. BEIR VII offers a full review of the available biological, biophysical, and epidemiological literature since the last BEIR report on the subject and develops the most up-to-date and comprehensive risk estimates for cancer and other health effects from exposure to low-level ionizing radiation.