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Exposure-Response Modeling

Exposure-Response Modeling PDF Author: Jixian Wang
Publisher: CRC Press
ISBN: 146657321X
Category : Mathematics
Languages : en
Pages : 348

Book Description
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

Exposure-Response Modeling

Exposure-Response Modeling PDF Author: Jixian Wang
Publisher: CRC Press
ISBN: 146657321X
Category : Mathematics
Languages : en
Pages : 348

Book Description
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

Science and Decisions

Science and Decisions PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309120462
Category : Political Science
Languages : en
Pages : 422

Book Description
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.

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
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163

Book Description
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.

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
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236

Book Description
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)

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
ISBN: 0309173841
Category : Nature
Languages : en
Pages : 226

Book Description
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.

Mathematical Models for Estimating Occupational Exposure to Chemicals

Mathematical Models for Estimating Occupational Exposure to Chemicals PDF Author: Wil F. Ten Berge
Publisher: AIHA
ISBN: 0932627994
Category : Chemical models
Languages : en
Pages : 120

Book Description
Discusses mathematical exposure models which may assist industrial hygienists in determining acceptable exposure limits in the workplace.

Drinking Water and Health, Volume 8

Drinking Water and Health, Volume 8 PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309037751
Category : Nature
Languages : en
Pages : 507

Book Description
Pharmacokinetics, the study of the movement of chemicals within the body, is a vital tool in assessing the risk of exposure to environmental chemicals. This bookâ€"a collection of papers authored by experts in academia, industry, and governmentâ€"reviews the progress of the risk-assessment process and discusses the role of pharmacokinetic principles in evaluating risk. In addition, the authors discuss software packages used to analyze data and to build models simulating biological phenomena. A summary chapter provides a view of trends in pharmacokinetic modeling and notes some prospective fields of study.

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
ISBN: 0309086094
Category : Medical
Languages : en
Pages : 187

Book Description
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.

Dose-Response Analysis Using R

Dose-Response Analysis Using R PDF Author: Christian Ritz
Publisher: CRC Press
ISBN: 1351981048
Category : Mathematics
Languages : en
Pages : 227

Book Description
Nowadays the term dose-response is used in many different contexts and many different scientific disciplines including agriculture, biochemistry, chemistry, environmental sciences, genetics, pharmacology, plant sciences, toxicology, and zoology. In the 1940 and 1950s, dose-response analysis was intimately linked to evaluation of toxicity in terms of binary responses, such as immobility and mortality, with a limited number of doses of a toxic compound being compared to a control group (dose 0). Later, dose-response analysis has been extended to other types of data and to more complex experimental designs. Moreover, estimation of model parameters has undergone a dramatic change, from struggling with cumbersome manual operations and transformations with pen and paper to rapid calculations on any laptop. Advances in statistical software have fueled this development. Key Features: Provides a practical and comprehensive overview of dose-response analysis. Includes numerous real data examples to illustrate the methodology. R code is integrated into the text to give guidance on applying the methods. Written with minimal mathematics to be suitable for practitioners. Includes code and datasets on the book’s GitHub: https://github.com/DoseResponse. This book focuses on estimation and interpretation of entirely parametric nonlinear dose-response models using the powerful statistical environment R. Specifically, this book introduces dose-response analysis of continuous, binomial, count, multinomial, and event-time dose-response data. The statistical models used are partly special cases, partly extensions of nonlinear regression models, generalized linear and nonlinear regression models, and nonlinear mixed-effects models (for hierarchical dose-response data). Both simple and complex dose-response experiments will be analyzed.

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
ISBN: 0309133343
Category : Science
Languages : en
Pages : 422

Book Description
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.