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Author: Jixian Wang
Publisher: CRC Press
Published: 2015-07-17
Total Pages: 348
ISBN-13: 146657321X
DOWNLOAD EBOOKDiscover 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
Author: National Research Council
Publisher: National Academies Press
Published: 2010-12-21
Total Pages: 163
ISBN-13: 030918651X
DOWNLOAD EBOOKRandomized 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.
Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
Published: 2013-02-21
Total Pages: 236
ISBN-13: 1587634236
DOWNLOAD EBOOKThis 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)
Author: National Research Council
Publisher: National Academies Press
Published: 1998-07-24
Total Pages: 226
ISBN-13: 0309173841
DOWNLOAD EBOOKThe 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.
Author: National Research Council
Publisher: National Academies Press
Published: 2002-11-30
Total Pages: 187
ISBN-13: 0309086094
DOWNLOAD EBOOKEPA 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.
Author: National Research Council
Publisher: National Academies Press
Published: 1987-02-01
Total Pages: 507
ISBN-13: 0309037751
DOWNLOAD EBOOKPharmacokinetics, 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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-05-04
Total Pages: 147
ISBN-13: 0309440513
DOWNLOAD EBOOKMarine mammals face a large array of stressors, including loss of habitat, chemical and noise pollution, and bycatch in fishing, which alone kills hundreds of thousands of marine mammals per year globally. To discern the factors contributing to population trends, scientists must consider the full complement of threats faced by marine mammals. Once populations or ecosystems are found to be at risk of adverse impacts, it is critical to decide which combination of stressors to reduce to bring the population or ecosystem into a more favorable state. Assessing all stressors facing a marine mammal population also provides the environmental context for evaluating whether an additional activity could threaten it. Approaches to Understanding the Cumulative Effects of Stressors on Marine Mammals builds upon previous reports to assess current methodologies used for evaluating cumulative effects and identify new approaches that could improve these assessments. This review focuses on ways to quantify exposure-related changes in the behavior, health, or body condition of individual marine mammals and makes recommendations for future research initiatives.
Author: Wil F. Ten Berge
Publisher: AIHA
Published: 2000
Total Pages: 120
ISBN-13: 0932627994
DOWNLOAD EBOOKDiscusses mathematical exposure models which may assist industrial hygienists in determining acceptable exposure limits in the workplace.
Author: Philippa D. Darbre
Publisher: Academic Press
Published: 2015-03-21
Total Pages: 390
ISBN-13: 0128011203
DOWNLOAD EBOOKEndocrine Disruption and Human Health starts with an overview of what endocrine disruptors are, the issues surrounding them, and the source of these chemicals in the ecosystem. This is followed by an overview of the mechanisms of action and assay systems. The third section includes chapters written by specialists on different aspects of concern for the effects of endocrine disruption on human health. Finally, the authors consider the risk assessment of endocrine disruptors and the pertinent regulation developed by the EU, the US FDA, as well as REACH and NGOs. The book has been written for researchers and research clinicians interested in learning about the actions of endocrine disruptors and current evidence justifying concerns for human health but is useful for those approaching the subject for the first time, graduate students, and advanced undergraduate students. - Provides readers with access to a range of information from the basic mechanisms and assays to cutting-edge research investigating concerns for human health - Presents a comprehensive, translational look at all aspects of endocrine disruption and its effects on human health - Offers guidance on the risk assessment of endocrine disruptors and current relevant regulatory considerations
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-01-01
Total Pages: 221
ISBN-13: 0309171148
DOWNLOAD EBOOKClinical 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.
