Committee on Scientific Standards for Studies on Modified Risk Tobacco Products's Books

Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

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Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

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370

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National Academies Press

Published Date

ISBN 10

0309223989

ISBN 13

9780309223980

Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

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Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

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370

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National Academies Press

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ISBN 10

0309223989

ISBN 13

9780309223980

Understanding the U.S. Illicit Tobacco Market

Characteristics, Policy Context, and Lessons from International Experiences

By: National Research Council,Committee on the Illicit Tobacco Market: Collection and Analysis of the International Experience

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Understanding the U.S. Illicit Tobacco Market

Characteristics, Policy Context, and Lessons from International Experiences

By: National Research Council,Committee on the Illicit Tobacco Market: Collection and Analysis of the International Experience

Tobacco use has declined because of measures such as high taxes on tobacco products and bans on advertising, but worldwide there are still more than one billion people who regularly use tobacco, including many who purchase products illicitly. By contrast to many other commodities, taxes comprise a substantial portion of the retail price of cigarettes in the United States and most other nations. Large tax differentials between jurisdictions increase incentives for participation in existing illicit tobacco markets. In the United States, the illicit tobacco market consists mostly of bootlegging from low-tax states to high-tax states and is less affected by large-scale smuggling or illegal production as in other countries. In the future, nonprice regulation of cigarettes - such as product design, formulation, and packaging - could in principle, contribute to the development of new types of illicit tobacco markets. Understanding the U.S. Illicit Tobacco Market reviews the nature of illicit tobacco markets, evidence for policy effects, and variations among different countries with a focus on implications for the United States. This report estimates the portion of the total U.S. tobacco market represented by illicit sales has grown in recent years and is now between 8.5 percent and 21 percent. This represents between 1.24 to 2.91 billion packs of cigarettes annually and between $2.95 billion and $6.92 billion in lost gross state and local tax revenues. Understanding the U.S. Illicit Tobacco Market describes the complex system associated with illicit tobacco use by exploring some of the key features of that market - the cigarette supply chain, illicit procurement schemes, the major actors in the illicit trade, and the characteristics of users of illicit tobacco. This report draws on domestic and international experiences with the illicit tobacco trade to identify a range of possible policy and enforcement interventions by the U.S. federal government and/or states and localities.

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316

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National Academies Press

Published Date

ISBN 10

0309317150

ISBN 13

9780309317153

Controlled Human Inhalation-Exposure Studies at EPA

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

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Controlled Human Inhalation-Exposure Studies at EPA

The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.

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159

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National Academies Press

Published Date

ISBN 10

030945252X

ISBN 13

9780309452526

Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Implications of Raising the Minimum Age for Purchasing Tobacco Products

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Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Implications of Raising the Minimum Age for Purchasing Tobacco Products

Tobacco use by adolescents and young adults poses serious concerns. Nearly all adults who have ever smoked daily first tried a cigarette before 26 years of age. Current cigarette use among adults is highest among persons aged 21 to 25 years. The parts of the brain most responsible for cognitive and psychosocial maturity continue to develop and change through young adulthood, and adolescent brains are uniquely vulnerable to the effects of nicotine. At the request of the U.S. Food and Drug Administration, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products considers the likely public health impact of raising the minimum age for purchasing tobacco products. The report reviews the existing literature on tobacco use patterns, developmental biology and psychology, health effects of tobacco use, and the current landscape regarding youth access laws, including minimum age laws and their enforcement. Based on this literature, the report makes conclusions about the likely effect of raising the minimum age to 19, 21, and 25 years on tobacco use initiation. The report also quantifies the accompanying public health outcomes based on findings from two tobacco use simulation models. According to the report, raising the minimum age of legal access to tobacco products, particularly to ages 21 and 25, will lead to substantial reductions in tobacco use, improve the health of Americans across the lifespan, and save lives. Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products will be a valuable reference for federal policy makers and state and local health departments and legislators.

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341

Publisher

National Academies Press

Published Date

ISBN 10

0309316278

ISBN 13

9780309316279

Assessing the Use of Agent-Based Models for Tobacco Regulation

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Agent-Based Models to Inform Tobacco Product Regulation

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Assessing the Use of Agent-Based Models for Tobacco Regulation

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Agent-Based Models to Inform Tobacco Product Regulation

Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco. Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.

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269

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National Academies Press

Published Date

ISBN 10

0309317258

ISBN 13

9780309317252

Clearing the Smoke

Assessing the Science Base for Tobacco Harm Reduction

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee to Assess the Science Base for Tobacco Harm Reduction

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Clearing the Smoke

Assessing the Science Base for Tobacco Harm Reduction

By: Institute of Medicine,Board on Health Promotion and Disease Prevention,Committee to Assess the Science Base for Tobacco Harm Reduction

Despite overwhelming evidence of tobacco's harmful effects and pressure from anti-smoking advocates, current surveys show that about one-quarter of all adults in the United States are smokers. This audience is the target for a wave of tobacco products and pharmaceuticals that claim to preserve tobacco pleasure while reducing its toxic effects. Clearing the Smoke addresses the problems in evaluating whether such products actually do reduce the health risks of tobacco use. Within the context of regulating such products, the committee explores key questions: Does the use of such products decrease exposure to harmful substances in tobacco? Is decreased exposure associated with decreased harm to health? Are there surrogate indicators of harm that could be measured quickly enough for regulation of these products? What are the public health implications? This book looks at the types of products that could reduce harm and reviews the available evidence for their impact on various forms of cancer and other major ailments. It also recommends approaches to governing these products and tracking their public health effects. With an attitude of healthy skepticism, Clearing the Smoke will be important to health policy makers, public health officials, medical practitioners, manufacturers and marketers of "reduced-harm" tobacco products, and anyone trying to sort through product claims.

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657

Publisher

National Academies Press

Published Date

ISBN 10

0309072824

ISBN 13

9780309072823

Biosocial Surveys

By: National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Population,Committee on Advances in Collecting and Utilizing Biological Indicators and Genetic Information in Social Science Surveys

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Biosocial Surveys

Biosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewerâ€"respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.

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428

Publisher

National Academies Press

Published Date

ISBN 10

0309164370

ISBN 13

9780309164375

Genomic medicine

2nd report of session 2008-09, Vol. 2: Evidence

By: Great Britain: Parliament: House of Lords: Science and Technology Committee

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Genomic medicine

2nd report of session 2008-09, Vol. 2: Evidence

By: Great Britain: Parliament: House of Lords: Science and Technology Committee

Volume 1 Report also available (ISBN 9780108444517). Genomic medicine has developed from the sequencing of the human genome

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652

Publisher

The Stationery Office

Published Date

ISBN 10

0108444503

ISBN 13

9780108444500

Effects of Ionizing Radiation

UNSCEAR 2006 Report to the General Assembly, with Scientific Annexes

By: United Nations. Scientific Committee on the Effects of Atomic Radiation

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Effects of Ionizing Radiation

UNSCEAR 2006 Report to the General Assembly, with Scientific Annexes

By: United Nations. Scientific Committee on the Effects of Atomic Radiation

The purpose of this annex is to summarize the literature on non-targeted effects associated with exposure to ionizing radiation and, where possible, to evaluate how such effects may affect risks associated with radiation exposure, the understanding of radiation-induced carcinogenesis, and the mechanistic basis for interpreting epidemiological data on radiation effects.

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344

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United Nations Publications

Published Date

ISBN 10

9211422701

ISBN 13

9789211422702

Book's by Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products

Scientific Standards for Studies on Modified Risk Tobacco Products

Understanding the U.S. Illicit Tobacco Market

Understanding the U.S. Illicit Tobacco Market

Controlled Human Inhalation-Exposure Studies at EPA

Controlled Human Inhalation-Exposure Studies at EPA

Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products

Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products

Assessing the Use of Agent-Based Models for Tobacco Regulation

Assessing the Use of Agent-Based Models for Tobacco Regulation

Clearing the Smoke

Clearing the Smoke

Biosocial Surveys

Biosocial Surveys

Genomic medicine

Genomic medicine

Effects of Ionizing Radiation

Effects of Ionizing Radiation

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