Download or read book Center for Devices and Radiological Health Toxicology Risk Assessment Committee Report written by Center for Devices and Radiological Health (U.S.). Toxicology Risk Assessment Committee and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Is the FDA Protecting Patients from the Dangers of Silicone Breast Implants written by United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee and published by . This book was released on 1991 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Annual Report of the Office of Science and Technology written by Center for Devices and Radiological Health (U.S.). Office of Science and Technology and published by . This book was released on 1986 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Annual Report of the Division of Risk Assessment National Center for Devices and Radiological Health written by and published by . This book was released on 1981 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-10-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

Download or read book Risk Assessment and Risk Management of Toxic Substances written by and published by . This book was released on 1985 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Download or read book Final Report of the Advisory Committee on the Food and Drug Administration written by United States. Department of Health and Human Services. Advisory Committee on the Food and Drug Administration and published by . This book was released on 1991 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Exposure and Risk Assessment of Chemical Pollution Contemporary Methodology written by Mahmoud A. Hassanien and published by Springer Science & Business Media. This book was released on 2009-03-31 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book contains the contributions at the NATO Study Institute on Exposure and Risk Assessment of Chemical Pollution – Contemporary Methodology, which took place in Sofia – Borovetz, Bulgaria, July 1–10, 2008. Rapid advances in mathematics, computer science and molecular biology and chemistry have lead to the development in of a new branch of toxicology called Computational Toxicology. This emerging field is addressing the estimation and prediction of exposure risk and effects of chemicals based on experimental data, measured concentration and biological mechanisms and computational models of biological systems. Mathematical models are also being used to predict the fate and transport of substances in the environment. Because this area is still in its infancy, there has been limited application from governmental agencies to regulating controllable processes, such as registration of new chemicals, determination of estimated exposure and risk based limits and maximum acceptable concentrations in different compartments of the environment – ambient air, waters, soil and food products. However, this is soon to change as the ability to collect, analyze and interpret the required information is becoming increasingly more efficient and cost effective. Full implementation of the new processes have to involve education on both part of the experimentalists who are generating the data and the models, and the risk assessors who will use them to better protect human health and the environment.

Download or read book Regulatory Toxicology Third Edition written by Shayne C. Gad and published by CRC Press. This book was released on 2018-09-03 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: • Describes regulatory testing requirements for all the major classes of marketed products • Explains how to prepare required documents for mandated safety testing of product • Features new chapters addressing Safety Data Sheet Preparation and Regulatory Requirements for GMOs • Covers Safety Data Sheet Preparation, which has replaced the Material Safety Data Sheet system

Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1993 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.

Download or read book Technical Report Series written by and published by . This book was released on 2004 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Download or read book Federal Register written by and published by . This book was released on 2018 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Toxicity Pathway Based Risk Assessment written by National Research Council and published by National Academies Press. This book was released on 2010-07-07 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2007, the National Research Council envisioned a new paradigm in which biologically important perturbations in key toxicity pathways would be evaluated with new methods in molecular biology, bioinformatics, computational toxicology, and a comprehensive array of in vitro tests based primarily on human biology. Although some considered the vision too optimistic with respect to the promise of the new science, no one can deny that a revolution in toxicity testing is under way. New approaches are being developed, and data are being generated. As a result, the U.S. Environmental Protection Agency (EPA) expects a large influx of data that will need to be evaluated. EPA also is faced with tens of thousands of chemicals on which toxicity information is incomplete and emerging chemicals and substances that will need risk assessment and possible regulation. Therefore, the agency asked the National Research Council to convene a symposium to stimulate discussion on the application of the new approaches and data in risk assessment. The symposium was held on May 11-13, 2009, in Washington, DC, and included presentations and discussion sessions on pathway-based approaches for hazard identification, applications of new approaches to mode-of-action analyses, the challenges to and opportunities for risk assessment in the changing paradigm, and future directions.

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.