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| elemental impurities risk assessment: Measuring Elemental Impurities in Pharmaceuticals Robert Thomas, 2018-01-29 Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand. |
| elemental impurities risk assessment: ICH Quality Guidelines Andrew Teasdale, David Elder, Raymond W. Nims, 2017-09-29 Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP) |
| elemental impurities risk assessment: Instrumentation Reference Book Walt Boyes, 2009-11-25 The discipline of instrumentation has grown appreciably in recent years because of advances in sensor technology and in the interconnectivity of sensors, computers and control systems. This 4e of the Instrumentation Reference Book embraces the equipment and systems used to detect, track and store data related to physical, chemical, electrical, thermal and mechanical properties of materials, systems and operations. While traditionally a key area within mechanical and industrial engineering, understanding this greater and more complex use of sensing and monitoring controls and systems is essential for a wide variety of engineering areas--from manufacturing to chemical processing to aerospace operations to even the everyday automobile. In turn, this has meant that the automation of manufacturing, process industries, and even building and infrastructure construction has been improved dramatically. And now with remote wireless instrumentation, heretofore inaccessible or widely dispersed operations and procedures can be automatically monitored and controlled. This already well-established reference work will reflect these dramatic changes with improved and expanded coverage of the traditional domains of instrumentation as well as the cutting-edge areas of digital integration of complex sensor/control systems. - Thoroughly revised, with up-to-date coverage of wireless sensors and systems, as well as nanotechnologies role in the evolution of sensor technology - Latest information on new sensor equipment, new measurement standards, and new software for embedded control systems, networking and automated control - Three entirely new sections on Controllers, Actuators and Final Control Elements; Manufacturing Execution Systems; and Automation Knowledge Base - Up-dated and expanded references and critical standards |
| elemental impurities risk assessment: Mutagenic Impurities Andrew Teasdale, 2022-02-15 Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control. |
| elemental impurities risk assessment: WHO Guidelines for Assessing Quality of Herbal Medicines with Reference to Contaminants and Residues , 2007 |
| elemental impurities risk assessment: Usp38-Nf33 United States Pharmacopeial Convention, 2014-11-01 |
| elemental impurities risk assessment: Genotoxic Impurities Andrew Teasdale, 2011-03-29 This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities. |
| elemental impurities risk assessment: Elemental Speciation in Human Health Risk Assessment P. Apostoli, World Health Organization, United Nations Environment Programme, International Labour Organisation, 2006 Definitions of species and speciation - - Strructural aspects of speciation - - Analytical techniques and methodology - - Bioaccessibility and bioavailability - - Toxicokinetics and biological monitoring - - Molecular and cellular mechanisms of metal toxicity - - Health effects - - Conclusions and recommendations. |
| elemental impurities risk assessment: Development and Validation of Analytical Methods Christopher M. Riley, Thomas W. Rosanske, 1996-05-29 The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation. |
| elemental impurities risk assessment: Quality Management and Quality Control Paulo Pereira, Sandra Xavier, Sandra Maria Miranda Xavier Da Silva, 2019 Quality management (QM) practices are the basis for the successful implementation and maintenance of any QM system. Quality control (QC) is identified as a QM component. Therefore, QM effectiveness is dependent on the QC strategy. QC practice is more or less complex depending on the type of production. The book is focused on new trends and developments in QM and QC in several types of industries from a worldwide perspective. Its content has been organized into two sections and seven chapters written by well-recognized researchers worldwide. Several approaches are debated based on sample traceability, analytical method validation, required parameters, class of exponential regression-type estimators of the population means, determination of impurities, viewpoints, and case studies. |
| elemental impurities risk assessment: Leachables and Extractables Handbook Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao, 2012-01-24 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. |
| elemental impurities risk assessment: Single-Use Technology in Biopharmaceutical Manufacture Regine Eibl, Dieter Eibl, 2019-07-18 Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system. |
| elemental impurities risk assessment: Measuring Elemental Impurities in Pharmaceuticals Robert Thomas, 2018-01-29 Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand. |
| elemental impurities risk assessment: Computational Toxicology Bruce A. Fowler, 2013-06-04 Computational Toxicology: Methods and Applications for Risk Assessment is an essential reference on the translation of computational toxicology data into information that can be used for more informed risk assessment decision-making. This book is authored by leading international investigators who have real-world experience in relating computational toxicology methods to risk assessment. Key topics of interest include QSAR modeling, chemical mixtures, applications to metabolomic and metabonomic data sets, toxicogenomic analyses, applications to REACH informational strategies and much more. The examples provided in this book are based on cutting-edge technologies and set out to stimulate the further development of this promising field to offer rapid, better and more cost-effective answers to major public health concerns. Authored by leading international researchers engaged in cutting-edge applications of computational methods for translating complex toxicological data sets into useful risk assessment information Incorporates real-world examples of how computational toxicological methods have been applied to advance the science of risk assessment Provides the framework necessary for new technologies and fosters common vocabularies and principles upon which the effects of new chemical entities should be compared |
| elemental impurities risk assessment: Sample Preparation for Trace Element Analysis Zoltan Mester, Ralph E. Sturgeon, 2003-12-16 Following the collection of a sample, every analytical chemist will agree that its subsequent preservation and processing are of paramount importance. The availability of high performance analytical instrumentation has not diminished this need for careful selection of appropriate pretreatment methodologies, intelligently designed to synergistically elicit optimum function from these powerful measurement tools. Sample Preparation for Trace Element Analysis is a modern, comprehensive treatise, providing an account of the state-of-the art on the subject matter. The book has been conceived and designed to satisfy the varied needs of the practicing analytical chemist. It is a multi-author work, reflecting the diverse expertise arising from its highly qualified contributors. The first five chapters deal with general issues related to the determination of trace metals in varied matrices, such as sampling, contamination control, reference materials, calibration and detection techniques. The second part of the book deals with extraction and sampling technologies (totaling 15 chapters), providing theoretical and practical hints for the users on how to perform specific extractions. Subsequent chapters overview seven major representative matrices and the sample preparation involved in their characterization. This portion of the book is heavily based on the preceding chapters dealing with extraction technologies. The last ten chapters are dedicated to sample preparation for trace element speciation.- First title to provide comprehensive sample preparation information, dealing specifically with the analysis of samples for trace elements. - The 39 chapters are authored by international leaders of their fields. |
| elemental impurities risk assessment: Practical Guide to ICP-MS Robert Thomas, 2003-12-11 Written by a field insider with more than 20 years of experience in the development and application of atomic spectroscopy instrumentation, the Practical Guide to ICP-MS offers key concepts and guidelines in a reader-friendly format that is superb for those with limited knowledge of the technique. This reference discusses the fundamental principles, analytical advantages, practical capabilities, and overall benefits of ICP-MS. It presents the most important selection criteria when evaluating commercial ICP-MS equipment and the most common application areas of ICP-MS such as the environmental, semiconductor, geochemical, clinical, nuclear, food, metallurgical, and petrochemical industries. |
| elemental impurities risk assessment: Extractables and Leachables Dennis Jenke, 2022-08-02 EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing. |
| elemental impurities risk assessment: Trace Elements in Terrestrial Environments Domy C. Adriano, 2013-03-19 A comprehensive reference handbook on the important aspects of trace elements in the land environment. Each chapter addresses a particular element and gives a general introduction to their role in the environment, where they come from, and their biogeochemical cycles. In addition to a complete updating of each of the element chapters, this new edition has new chapters devoted to aluminum and iron, soil contamination, remediation and trace elements in aquatic ecosystems. In short, an essential resource for environmental scientists and chemists, regulators and policy makers. |
| elemental impurities risk assessment: Innovative Dosage Forms Yogeshwar Bachhav, 2019-12-04 Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists. |
| elemental impurities risk assessment: Antibody-Drug Conjugates Kenneth J. Olivier, Jr., Sara A. Hurvitz, 2016-11-14 Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development |
| elemental impurities risk assessment: Ecological Risk Assessment Glenn W. Suter II, 1992-10-23 Recently, environmental scientists have been required to perform a new type of assessment-ecological risk assessment. This is the first book that explains how to perform ecological risk assessments and gives assessors access to the full range of useful data, models, and conceptual approaches they need to perform an accurate assessment. It explains how ecological risk assessment relates to more familiar types of assessments. It also shows how to organize and conduct an ecological risk assessment, including defining the source, selecting endpoints, describing the relevant features of the receiving environment, estimating exposure, estimating effects, characterizing the risks, and interacting with the risk manager. Specific technical topics include finding and selecting toxicity data; statistical and mathematical models of effects on organisms, populations, and ecosystems; estimation of chemical fate parameters; modeling of chemical transport and fate; estimation of chemical uptake by organisms; and estimation, propagation, and presentation of uncertainty. Ecological Risk Assessment also covers conventional risk assessments, risk assessments for existing contamination, large scale problems, exotic organisms, and risk assessments based on environmental monitoring. Environmental assessors at regulatory agencies, consulting firms, industry, and government labs need this book for its approaches and methods for ecological risk assessment. Professors in ecology and other environmental sciences will find the book's practical preparation useful for classroom instruction. Environmental toxicologists and chemists will appreciate the discussion of the utility for risk assessment of particular toxicity tests and chemical determinations. |
| elemental impurities risk assessment: Public Health Consequences of E-Cigarettes National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, 2018-05-18 Millions of Americans use e-cigarettes. Despite their popularity, little is known about their health effects. Some suggest that e-cigarettes likely confer lower risk compared to combustible tobacco cigarettes, because they do not expose users to toxicants produced through combustion. Proponents of e-cigarette use also tout the potential benefits of e-cigarettes as devices that could help combustible tobacco cigarette smokers to quit and thereby reduce tobacco-related health risks. Others are concerned about the exposure to potentially toxic substances contained in e-cigarette emissions, especially in individuals who have never used tobacco products such as youth and young adults. Given their relatively recent introduction, there has been little time for a scientific body of evidence to develop on the health effects of e-cigarettes. Public Health Consequences of E-Cigarettes reviews and critically assesses the state of the emerging evidence about e-cigarettes and health. This report makes recommendations for the improvement of this research and highlights gaps that are a priority for future research. |
| elemental impurities risk assessment: How Tobacco Smoke Causes Disease United States. Public Health Service. Office of the Surgeon General, 2010 This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products. |
| elemental impurities risk assessment: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| elemental impurities risk assessment: Industrial Crystallization J. Mullin, 2012-12-06 Industrial Crystallization Symposia have been organized by the Crystallization Research Group at the Czechoslovak Research Institute for Inorganic Chemistry, Usti nad Labem, since 1960. Over the years, the increasing popularity of the unit operation of crystallization has been clearly demonstrated by the steady increase in numbers of both the papers presented and the attendances at the meetings. The 6th Symposium (1-3 September 1975) was organized jointly with the European Federation of Chemical Engineering Working Party on Crystallization, and the 44 papers presented were arranged into four sessions - A: Secondary Nucleation, B: Crystal Growth Kinetics, C: Crystal Habit Modification, D: Crystallizer Design, E: Indus trial Crystallizer Operation and Case Studies. The same groupings are preserved in this edited version of the proceedings. This is the first time that the Industrial Crystallization Symposium papers have appeared in one volume. After the 5th (1972) Symposium, authors we.re encouraged to submit their papers to an international journal specializing in crystallization. However, the results were not altogether satisfactory in that less than one third of the papers presented at the meeting were offered for consideration. This time, therefore, the organizing committee decided to attempt to keep the papers together by making arrangements for their pUblication by Plenum Press. |
| elemental impurities risk assessment: Pharmaceutical Industry Practices on Genotoxic Impurities Heewon Lee, 2014-08-29 A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati |
| elemental impurities risk assessment: Infant Formula Institute of Medicine, Food and Nutrition Board, Committee on the Evaluation of the Addition of Ingredients New to Infant Formula, 2004-06-10 Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants. |
| elemental impurities risk assessment: OECD Guidelines for Testing of Chemicals Organisation for Economic Co-operation and Development, 1981 |
| elemental impurities risk assessment: Chemical Products and Processes Konrad Hungerbühler, Justin M. Boucher, Cecilia Pereira, Thomas Roiss, Martin Scheringer, 2021-03-17 This textbook provides both students and professionals alike with a transdisciplinary and comprehensive foundation to design responsible chemical products and processes that protect human health and the environment. It serves as a compact guide that brings together knowledge and tools from across multiple disciplines. Readers are introduced to a set of core topics with focus placed on basic technical methods and tools (including life cycle assessment, product and process risk assessment, and thermal safety concepts) as well as on important normative topics (including philosophical, societal, and business perspectives in addition to current environmental and safety legislation). Developed in collaboration with industry partners, this textbook also provides a workable, illustrative case study that guides readers through applying the fundamentals learned to the production and application of a real-world chemical product. Building upon the success of its first German edition published in 1998, this latest edition has been significantly updated and expanded to reflect developments over the past two decades. Its publication comes at a key time when the volume and pace of global chemical production is dramatically increasing, and the rise of social media and informed citizen scientists make the dialogue with stakeholders even more important and demanding. This textbook is a valuable resource for both the current and next generation of scientists and engineers that will be tasked with addressing the many challenges and opportunities that are appearing as a result. Covering a wide range of interconnected topics at a fundamental level applicable across scientific study programs and professions, this textbook fills a need not met by many of the other more specialized textbooks currently available. |
| elemental impurities risk assessment: Metals and the Skin Richard H. Guy, 1999-04-05 Addresses the increase of toxic heavy metals in the environment. Sets the standard for future research in interactions between the skin and metals and metal compounds-covering the general toxicology of 35 metals and metalloids, their occurrence in the environment, significance in nutrition, skin diffusivity, occupational exposure risks, and immunotoxicity. |
| elemental impurities risk assessment: Recommendations on the Transport of Dangerous Goods United Nations, 2020-01-06 The Manual of Tests and Criteria contains criteria, test methods and procedures to be used for classification of dangerous goods according to the provisions of Parts 2 and 3 of the United Nations Recommendations on the Transport of Dangerous Goods, Model Regulations, as well as of chemicals presenting physical hazards according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). As a consequence, it supplements also national or international regulations which are derived from the United Nations Recommendations on the Transport of Dangerous Goods or the GHS. At its ninth session (7 December 2018), the Committee adopted a set of amendments to the sixth revised edition of the Manual as amended by Amendment 1. This seventh revised edition takes account of these amendments. In addition, noting that the work to facilitate the use of the Manual in the context of the GHS had been completed, the Committee considered that the reference to the Recommendations on the Transport of Dangerous Goods in the title of the Manual was no longer appropriate, and decided that from now on, the Manual should be entitled Manual of Tests and Criteria. |
| elemental impurities risk assessment: The Basics of FMEA Raymond J. Mikulak, 2017-08-09 Demonstrates How To Perform FMEAs Step-by-StepOriginally designed to address safety concerns, Failure Mode and Effect Analysis (FMEA) is now used throughout the industry to prevent a wide range of process and product problems. Useful in both product design and manufacturing, FMEA can identify improvements early when product and process changes are |
| elemental impurities risk assessment: Isotopic Analysis Frank Vanhaecke, Patrick Degryse, 2012-04-24 Edited by two very well-known and respected scientists in the field, this excellent practical guide is the first to cover the fundamentals and a wide range of applications, as well as showing readers how to efficiently use this increasingly important technique. From the contents: * The Isotopic Composition of the Elements * Single-Collector ICP-MS * Multi-Collector ICP-MS * Advances in Laser Ablation - Multi-Collector ICP-MS * Correction for Instrumental Mass Discrimination in Isotope Ratio Determination with Multi-Collector ICP-MS * Reference Materials in Isotopic Analysis * Quality Control in Isotope Ratio Applications * Determination of Trace Elements and Elemental Species Using Isotope Dilution ICP-MS * Geochronological Dating * Application of Multi-Collector ICP-MS to Isotopic Analysis in Cosmochemistry * Establishing the Basis for Using Stable Isotope Ratios of Metals as Paleoredox Proxies * Isotopes as Tracers of Elements Across the Geosphere-Biosphere Interface * Archaeometric Applications * Forensics Applications * Nuclear Applications * The Use of Stable Isotope Techniques for Studying Mineral and Trace Element Metabolism in Humans * Isotopic Analysis via Multi-Collector ICP-MS in Elemental Speciation A must-have for newcomers as well as established scientists seeking an overview of isotopic analysis via ICP-MS. |
| elemental impurities risk assessment: Health Effects Assessment Summary Tables , 1997 |
| elemental impurities risk assessment: Guideline on General Principles of Process Validation , 1987 |
| elemental impurities risk assessment: Toxicological Profile for Copper , 2004 |
| elemental impurities risk assessment: Principles of Ecotoxicology, Second Edition C.H. Walker, R.M. Sibly, D.B. Peakall, 2003-09-02 Over the past decade ecotoxicology has emerged as a distinct subject of interdisciplinary character. Courses in ecotoxicology reflect this and are taught by specialists in chemistry and biochemistry through to population genetics and ecology. As the first textbook to incorporate all relevant aspects of chemistry, biochemistry, toxicology, physiology, population ecology and population genetics, the first edition of this book proved to be well received across several industries. Featuring fully revised text and new illustrations, Principles of Ecotoxicology identifies the major classes of organic and inorganic pollutants, their properties, release and environmental fate, and transport in air, water and along food chains, before considering the effects that they might have upon individual organisms and ultimately whole ecosystems. This timely second edition of Principles of Ecotoxicology incorporates data collected since the first edition on subjects of current research and media interest such as organochloride pesticides, endocrine disruptors, aquatic toxicity, industrial waste and ecotoxicity testing. |
| elemental impurities risk assessment: WHO Study Group on Tobacco Product Regulation World Health Organization, 2009 This report makes available the findings of an international group of experts that provide WHO with the latest scientific and technical advice in the area of product regulation. The third report presents the conclusions reached and recommendations made by the members of the WHO Study Group on Tobacco Product Regulation at its fifth meeting, during which it reviewed two background papers specially commissioned for the meeting and which dealt, respectively, with the following two themes: devices designed for the purpose of nicotine delivery to the respiratory system in which tobacco is not necessary for their operation and setting regulatory limits for carcinogens in smokeless tobacco. The Study Group's recommendations in relation to each theme are set out at the end of the section dealing with that theme. Its overall recommendations are summarized in section 4. The Study Group intends this new set of recommendations to be useful to WHO Member States and national policymakers and regulators in shaping tobacco control policy. |
| elemental impurities risk assessment: Dow's Fire and Explosion Index Hazard Classification Guide American Institute of Chemical Engineers (AIChE), 2016-03-21 This popular safety best-seller is designed to help the user quantify the expected damage of potential fire and explosion incidents in realistic terms, identify the equipment likely to contribute to the creation or escalation of an incident, and communicate the fire and explosion risk potential to management. Based on Dow's Fire and Explosion Risk Analysis Program, the index provides a step-by-step, objective evaluation of the actual fire and explosion, as well as reactivity potential of process equipment and its contents. |
| elemental impurities risk assessment: WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems World Health Organization, 2004-01-01 Safety is a fundamental principle in the privision of herbal medicines and herbal products for health care and a critical component of quality control. These guidelines provide practical technical guidance for monitoring the safety of herbal medicines with pharmacovigilance systems. |
Elemental (2023 film) - Wikipedia
Elemental is a 2023 American animated romantic comedy-drama film produced by Pixar Animation Studios for Walt Disney Pictures. Directed by Peter …
Elemental | Official Trailer - YouTube
This Summer, meet the residents of Element CityWatch the new trailer for Disney and Pixar’s #Elemental and see the movie in 3D, only in theaters …
Elemental (2023) - IMDb
Jun 16, 2023 · Elemental: Directed by Peter Sohn. With Leah Lewis, Mamoudou Athie, Ronnie Del Carmen, Shila Ommi. Follows Ember and …
Elemental - Disney Movies
Disney and Pixar’s “Elemental” is an all-new, original feature film set in Element City, where fire-, water-, land- and air residents live together.
Elemental (2023) - Rotten Tomatoes
Disney and Pixar's "Elemental," an all-new, original feature film set in Element City, where fire-, water-, land- and air-residents live together.
Elemental (2023 film) - Wikipedia
Elemental is a 2023 American animated romantic comedy-drama film produced by Pixar Animation Studios for Walt Disney Pictures. Directed by Peter Sohn and produced by Denise …
Elemental | Official Trailer - YouTube
This Summer, meet the residents of Element CityWatch the new trailer for Disney and Pixar’s #Elemental and see the movie in 3D, only in theaters June 16!Chec...
Elemental (2023) - IMDb
Jun 16, 2023 · Elemental: Directed by Peter Sohn. With Leah Lewis, Mamoudou Athie, Ronnie Del Carmen, Shila Ommi. Follows Ember and Wade, in a city where fire-, water-, earth- and air …
Elemental - Disney Movies
Disney and Pixar’s “Elemental” is an all-new, original feature film set in Element City, where fire-, water-, land- and air residents live together.
Elemental (2023) - Rotten Tomatoes
Disney and Pixar's "Elemental," an all-new, original feature film set in Element City, where fire-, water-, land- and air-residents live together.
Elemental — Pixar Animation Studios
Bernie Lumen is a Fire element with a big, crackling personality that burns with pride… about his homeland, about his daughter, Ember, and about the shop he runs in Element City. He and his …
Watch Elemental - Disney+
In a city where fire, water, land, and air residents live together, a fiery young woman and a go-with-the-flow guy are about to discover something elemental: How much they actually have in …
Elemental - Apple TV
Disney and Pixar’s “Elemental” is an original feature film set in Element City, where residents of Fire, Water, Earth and Air live together.
Elemental Cast & Characters: 17 Main Actors and Who They Play
Jun 15, 2023 · Here are the main actors who lend their voices to the colorful cast of Pixar's Elemental. Elemental will be Pixar’s 27th animated feature film. Per usual, the upcoming …
Elemental: Everything We Know So Far About Pixar's Next Film - Collider
Jun 2, 2023 · Dreamy, sweet, and definitely silly, the Elemental teaser trailer introduces viewers to the four different kinds of residents that reside in the Element City, along...
