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Highlighting key points from the latest regulatory requirements,
New Drug Development helps those new to the world of pharmaceutical
development understand regulatory steps, reduce cost by avoiding
unnecessary trials, and attain guidance through each step of the
drug approval process. This volume acquaints readers with
procedures that determine the success of drug development projects
with updated regulatory guidelines from the FDA and ICH, solutions
to hurdles in application protocols, and recommendations from more
than 40 respected and experience officials from regulatory agencies
around the globe. It covers topics related to the development of
chiral drugs, liposomal products, and more.
Examine several methods of testing for genetically modified organisms and the reasons behind their strict regulation! Testing of Genetically Modified Organisms in Foods is the first study of the screening methods and tools utilized for determining the presence of genetically modified organisms (GMOs) in food products. Leading experts in science, medicine, and government agencies examine the significant research and clinical developments in bio-engineered agriculture to bring you an accurate risk assessment of GMOs in relation to human consumption, economics, and the environment. This book focuses on three high-profile biotechnological commercial aspects of GMO inclusion in the world market: insect resistance, herbicide tolerance, and virus resistance. It also identifies new GM food crops that are in the laboratory and may soon be on your table. Testing of Genetically Modified Organisms in Foods looks at GMOs from the perspectives of both sides of the globe the European Union and the United States Department of Agriculture who each have their own set of rules and opinions regarding safety issues and marketing of bioengineered food products. This book looks at the government standards of scientific testing for GMOs, and several chapters specifically analyze current screening methods. This book also explores the impact of GMOs on farming, agricultural economy, pesticide control, and world famine. Testing of Genetically Modified Organisms in Foods brings you current information on: the risks and benefits of agricultural biotechnology to people and the environment the regulations and protocols of testing for GMOs that have been adopted by European and United States agencies scientific techniques that test for GMOs, including certified reference materials (CRMs) and matrix-based, protein-based, and DNA-based methods of testing the limitations of today's GMO screening methods and the benefits of alternatives that may be used in the future the long-term risks associated with gene flow of GMOs to other plants, specifically focusing on liabilities, regulatory climates, and intellectual property rights Testing of Genetically Modified Organisms in Foods is generously enhanced with figures, tables, and graphs as well as references at the end of every chapter. The commercialization of agricultural biotechnology makes this text essential for scientists, planners, and students of food, agriculture and environmental science. Government officials and activists will find this book invaluable in debating current issues of agricultural biotechnology and food safety.
This book examines the fundamental concepts of multimodality small-animal molecular imaging technologies and their numerous applications in biomedical research. Driven primarily by the widespread availability of various small-animal models of human diseases replicating accurately biological and biochemical processes in vivo, this is a relatively new yet rapidly expanding field that has excellent potential to become a powerful tool in biomedical research and drug development. In addition to being a powerful clinical tool, a number of imaging modalities including but not limited to CT, MRI, SPECT and PET are also used in small laboratory animal research to visualize and track certain molecular processes associated with diseases such as cancer, heart disease and neurological disorders in living small animal models of disease. In vivo small-animal imaging is playing a pivotal role in the scientific research paradigm enabling to understand human molecular biology and pathophysiology using, for instance, genetically engineered mice with spontaneous diseases that closely mimic human diseases.
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. - Guides researchers as to what drug safety experiments are both practical and useful - Covers a variety of key topics - safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and -omics tools - Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods - Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
This book describes the dynamics of low molecular weight and polymeric molecules when they are constrained under conditions of geometrical confinement. It covers geometrical confinement in different dimensionalities:
(i) in nanometer thin layers or self supporting films ("1-dimensional" confinement)
(ii) in pores or tubes with nanometric diameters ("2-dimensional" confinement)
(iii) as micelles embedded in matrices ("3-dimensional") or as nanodroplets.The dynamics under such conditions have been a much discussed and central topic in the focus of intense worldwide research activities within the last two decades. The present book discusses how the resulting molecular mobility is influenced by the subtle counterbalance between surface effects (typically slowing down molecular dynamics through attractive guest/host interactions) and confinement effects (typically increasing the mobility). It also explains how these influences can be modified and tuned, e.g. through appropriate surface coatings, film thicknesses or pore diameters. ""Dynamics in Confinement"" sums up the present state-of-the-art and introduces to the analytical methods of choice for the study of dynamics in nanometer-scale confinement.
Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.
This is the first monograph to specifically focus on fundamentals
and applications of polyelectrolytes, a class of molecules that
gained substantial interest due to their unique combination of
properties. Combining both features of organic semiconductors and
A GUIDE TO THE DESIGN, OPERATION, CONTROL, TROUBLESHOOTING, OPTIMIZATION AS WELL AS THE RECENT ADVANCES IN THE FIELD OF PETROCHEMICAL PROCESSES Efficient Petrochemical Processes: Technology, Design and Operation is a guide to the tools and methods for energy optimization and process design. Written by a panel of experts on the topic, the book highlights the application of these methods on petrochemical technology such as the aromatics process unit. The authors describe practical approaches and tools that focus on improving industrial energy efficiency, reducing capital investment, and optimizing yields through better design, operation, and optimization. The text is divided into sections that cover the range of essential topics: petrochemical technology description; process design considerations; reaction and separation design; process integration; process system optimization; types of revamps; equipment assessment; common operating issues; and troubleshooting case analysis. This important book: Provides the basic knowledge related to fundamentals, design, and operation for petrochemical processes Applies process integration techniques and optimization techniques that improve process design and operations in the petrochemical process Provides practical methods and tools for industrial practitioners Puts the focus on improving industrial energy efficiency, reducing capital investment, and optimizing yields Contains information on the most recent advances in the field. Written for managers, engineers, and operators working in process industries as well as university students, Efficient Petrochemical Processes: Technology, Design and Operation explains the most recent advances in the field of petrochemical processes and discusses in detail catalytic and adsorbent materials, reaction and separation mechanisms.
This book promotes understanding of the raw material selection, refractory design, tailor-made refractory developments, refractory properties, and methods of application. It provides a complete analysis of modern iron and steel refractories. It describes the daily demands on modern refractories and describes how these needs can be addressed or improved upon to help achieve the cleanest and largest yields of iron and steel. The text contains end-of-chapter summaries to help reinforce difficult concepts. It also includes problems at the end of chapters to confirm the reader's understanding of topics such as hoop stress modeling in steel ladle and vessels, establishment of thermal gradient modeling , refractory corrosion dynamics, calculation of Blast furnace trough dimension based on thermal modeling, to name a few. Led by editors with backgrounds in both academia and industry, this book can be used in college courses, as a reference for industry professionals, and as an introduction to the technology for those making the transition to industry. Stands as a comprehensive introduction to the science and technology of modern steel and iron-making refractories that examines the processes, construction, and potential improvement of refractory performance and sustainability; Serves as a versatile resource appropriate for all levels, from the student to industry novices to professionals; Reinforces difficult-to-grasp concepts with end-of-chapter summaries; Maximizes reader understanding of key topics, such as refractory selection for steel ladle and vessels, and their corrosion dynamics, with real life problems.
Considers groundbreaking developments in cosmeceuticals and the two-in-one shampoo Multifunctional Cosmetics examines the execution details one should consider when creating multifunctional products shows how to design tests to support claims considers the role of packaging in multifunctional products explores products designed to deliver, enhance, or prolong color as they clean and condition hair analyzes the growing importance of shower gels and bath products that perform multiple functions such as cleansing, conditioning, and coloring demonstrates how antiperspirants/deodorants use dually functional formulas to control body odor indicates how to introduce moisturizing or conditioning properties into products that have a different primary function Complemented by more than 300 references, figures, and tables, Multifunctional Cosmetics is an excellent resource for pharmaceutical formulation, cosmetic, and fragrance chemists, scientists, and technologists; cosmetics, pharmaceutical, chemical, and biochemical engineers; skin physiologists and biologists; pharmacists and pharmacologists; dermatologists; quality control and assurance managers; and regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.
This new volume provides a timely study on the environmental challenges from a specific class of perfluorinated chemical compounds (PFCs) that are now being recognized as a worldwide health threat. Recent studies report that levels of classes of PFCs known as polyfluoroalkyl and perfluoroalkyl (PFASs) exceed federally recommended safety levels in public drinking-water supplies for 6 million people in the United States and that as many as 100 million people could be at risk from exposure to these chemicals. These chemicals occur globally in wildlife and humans. Both PFCAs and PFSAs have been produced for more than 50 years, but have only become of interest to regulators and environmentalists since the late 1990s. Recent advances in analytical methodology has enabled widespread detection in the environment and humans at trace levels. These toxic chemicals have been found in outdoor and indoor air, surface and drinking water, house dust, animal tissue, human blood serum, and human breast milk. Of great concern to communities is the presence of these compounds in a number of drinking water supplies in the U.S. and other countries. This new volume provides a timely explanation of the chemicals, provides a detailed review of the regulations both in the US and European Community, explains the health risk literature, and then explores in great detail available treatment technologies. The volume is a must for public water supply facilities, industrial operations that have historically used these chemicals and face legacy pollution issues, policy makers and the general public.
A comprehensive textbook on petrochemical conversion processes for petroleum and natural gas fractions as produced by refinery operations This innovative textbook provides essential links between the chemical sciences and chemical technology, between petrochemistry and hydrocarbon technology. The book brings alive key concepts forming the basis of chemical technology and presents a solid background for innovative process development. In all chapters, the processes described are accompanied by simplified flow schemes, encouraging students to think in terms of conceptual process designs. Petrochemistry: Petrochemical Processing, Hydrocarbon Technology and Green Engineering introduces students to a variety of topics related to the petrochemical industry, hydrocarbon processing, fossil fuel resources, as well as fuels and chemicals conversion. The first chapter covers the fundamentals and principals for designing several of the processes in the book, including discussions on thermodynamics, chemical kinetics, reactor calculations, and industrial catalysts. The following chapters address recent advances in hydrocarbon technology, energy technology, and sources of hydrocarbons. The book then goes on to discuss the petrochemical industry based on four basic pillars, all derived from petroleum and natural gas: Production of lower alkenes; other sources of lower alkenes; petrochemicals from C2-C3 alkenes Production of BTX aromatics; chemicals from BTX aromatics C1 technology Diversification of petrochemicals The growing importance of sustainable technology, process intensification and addressing greenhouse gas emissions is reflected throughout the book. Written for advanced students working in the areas of petrochemistry, hydrocarbon technology, natural gas, energy materials and technologies, alternative fuels, and recycling technologies the book is also a valuable reference for industrial practitioners in the oil and gas industry.
This book provides a comprehensive overview of biomotors (molecular motors) within the body with a specific concentration on revolving molecular motors. The bioengineering of these new revolving molecular motors will go a long way in creating machines that will be able to carry RNA and DNA drugs directly to diseased cells to destroy them. The book goes into specific details regarding the bioengineering, fabrication, synthesis, and future utilization of these devices for nanomedicine.
A complete guide to the evolving methods by which we may recover by-products and significantly reduce food waste Across the globe, one third of cereals and almost half of all fruits and vegetables go to waste. The cost of such waste - both to economies and to the environment - is a serious and increasing concern within the food industry. If we are to overcome this crisis and move towards a sustainable future, we must do everything possible to utilize innovative new methods of extracting and processing valuable by-products of all kinds. Food Wastes and By-products represents a complete primer to this important and complex process. Edited and written by leading researchers, the text provides essential information on the supply of waste and its composition, identifies foods rich in valuable bioactive compounds, and explores revolutionary methods for creating by-products from fruit, vegetable, and seed waste. Other chapters discuss the nutraceutical properties of value-added by-products and their uses in the manufacturing of dietary fibers, food flavors, supplements, pectin, and more. This book: Explains how reconstituted by-products can best be used to radically reduce food waste Discusses the potential nutraceutical assets of recovered food waste Covers a broad range of by-product sources, such as mangos, cacao, flaxseed, and spent coffee grounds Describes novel extraction processes and the emerging use of nanotechnology A significant contribution to the field, Food Wastes and By-products is a timely and essential resource for food industry professionals, government agencies and NGOs involved in nutrition, agriculture, and food production, and university instructors and students in related areas.
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.
This brief describes the current critical situation of global warming and shows its solution by renewable energy use. The author has long studied the development of new materials with chemical functions and is renowned as the first advocate of power-to-gas. He established the technology to convert renewable energy to synthesized natural gas, methane by electrolytic hydrogen generation using surplus electricity from renewable energy, and subsequent methanation of carbon dioxide by reaction with hydrogen.In the first part of this brief, data on global warming and energy consumption are shown and analyzed from the author's keen point of view. The second part introduces the author's research results on key materials for global carbon dioxide recycling and constructed pilot plants based on them. Finally, an evidence-based solution to maintain sustainable development by using only renewable energy is described as a future prospect.This book is useful not only for researchers and students studying chemical engineering, materials, or energy, but also for general citizens who are interested in the global environment.
This book is the second volume of two volumes on cyclodextrins published in the series Environmental Chemistry for a Sustainable World. This volume focuses on cyclodextrin applications. The first chapter by Divya Arora and Sundeep Jaglan presents cyclodextrin-based carriers for delivery of dietary phytochemicals. The second chapter by Eva Fenyvesi et al. describes the interactions of steroids with cyclodextrins and their applications to pharmaceuticals, food, biotechnology and environment. Nazli Erdogar and Erem Bilensoy discuss cyclodextrin-based nanosystems in targeted cancer therapy. Miriana Kfoury et al. review the use of cyclodextrins for essential oils applications in chapter 4. Hiroshi Ikeda demonstrates in chapter 5 that chromophore-appended cyclodextrins are effective for chemosensors to detect organic molecules by fluorescence or absorbance changes. Then Gregorio Crini et al. describe silica materials-containing cyclodextrin for pollutant removal. The final chapter by Chang-Chun Ling et al. summarizes the synthesis and characterization of supramolecular liquid crystals based on cyclodextrins and their applications.
Molecular Techniques in Food Biology: Safety, Biotechnology, Authenticity & Traceability explores all aspects of microbe-food interactions, especially as they pertain to food safety. Traditional morphological, physiological, and biochemical techniques for the detection, differentiation, and identification of microorganisms have severe limitations. As an alternative, many of those responsible for monitoring food safety are turning to molecular tools for identifying foodborne microorganisms. This book reviews the latest molecular techniques for detecting, identifying, and tracing microorganisms in food, addressing both good foodborne microbes, such as those used for fermentation and in probiotics, and harmful ones responsible for foodborne illness and food quality control problems. Molecular Techniques in Food Biology: Safety, Biotechnology, Authenticity & Traceability brings together contributions by leading international authorities in food biology from academe, industry, and government. Chapters cover food microbiology, food mycology, biochemistry, microbial ecology, food biotechnology and bio-processing, food authenticity, food origin traceability, and food science and technology. Throughout, special emphasis is placed on novel molecular techniques relevant to food biology research and for monitoring and assessing food safety and quality. Brings together contributions from scientists at the leading edge of the revolution in molecular food biology Explores how molecular techniques can satisfy the dire need to deepen our understanding of how microbial communities develop in foods of all types and in all forms Covers all aspects of food safety and hygiene, microbial ecology, food biotechnology and bio-processing, food authenticity, food origin traceability, and more Fills a yawning gap in the world literature on food traceability using molecular techniques This book is an important working resource for professionals in agricultural, food science, biomedicine, and government involved in food regulation and safety. It is also an excellent reference for advanced students in agriculture, food science and food technology, biochemistry, microbiology, and biotechnology, as well as academic researchers in those fields.
AN AUTHORITATIVE GUIDE THAT EXPLAINS THE EFFECTIVENESS AND IMPLEMENTATION OF BOW TIE ANALYSIS, A QUALITATIVE RISK ASSESSMENT AND BARRIER MANAGEMENT METHODOLOGY From a collaborative effort of the Center for Chemical Process Safety (CCPS) and the Energy Institute (EI) comes an invaluable book that puts the focus on a specific qualitative risk management methodology - bow tie barrier analysis. The book contains practical advice for conducting an effective bow tie analysis and offers guidance for creating bow tie diagrams for process safety and risk management. Bow Ties in Risk Management clearly shows how bow tie analysis and diagrams fit into an overall process safety and risk management framework. Implementing the methods outlined in this book will improve the quality of bow tie analysis and bow tie diagrams across an organization and the industry. This important guide: Explains the proven concept of bow tie barrier analysis for the preventing and mitigation of incident pathways, especially related to major accidents Shows how to avoid common pitfalls and is filled with real-world examples Explains the practical application of the bow tie method throughout an organization Reveals how to treat human and organizational factors in a sound and practical manner Includes additional material available online Although this book is written primarily for anyone involved with or responsible for managing process safety risks, this book is applicable to anyone using bow tie risk management practices in other safety and environmental or Enterprise Risk Management applications. It is designed for a wide audience, from beginners with little to no background in barrier management, to experienced professionals who may already be familiar with bow ties, their elements, the methodology, and their relation to risk management. The missions of both the CCPS and EI include developing and disseminating knowledge, skills, and good practices to protect people, property and the environment by bringing the best knowledge and practices to industry, academia, governments and the public around the world through collective wisdom, tools, training and expertise. The CCPS has been at the forefront of documenting and sharing important process safety risk assessment methodologies for more than 30 years. The EI's Technical Work Program addresses the depth and breadth of the energy sector, from fuels and fuels distribution to health and safety, sustainability and the environment. The EI program provides cost-effective, value-adding knowledge on key current and future international issues affecting those in the energy sector.
This book is an essential guide and support to understanding of the science and policy, procedure and practice that underpins the REACH risk assessments required for the use and placing on the market of chemicals in the European Union. A clear understanding of information provision and how this affects the assessment of chemical safety is fundamentally important to the success of policy on chemicals and ultimately to the sustainability of the chemicals industry. Within the book, the scientific processes that underpin the policy are explained in a practical way. Importantly, it includes coverage of techniques to help solve the problems of using potentially risky and hazardous chemicals through the use of less hazardous alternatives and green chemistry , and also the analysis of the risks of the use of the most hazardous substances against the social and economic benefits of use. Chemical Risk Assessment: A Manual for REACH covers the following main themes: i) Assessment of chemical risk; ii) Risk management; iii) Hazard reduction, substitution and green chemistry; iv) Risk versus benefit socio-economic analysis. The book acts as a practical guide and overview to chemicals risk assessment and risk management (in the EU context), as well as a support text for planning for the challenges of the future, which will see ever-increasing pressure to withdraw hazardous substances from the EU (and global) market, balanced against opportunities for innovation in the development of less hazardous chemicals.
Rapeseed is now the second largest oilseed crop after soybean, and the third largest vegetable oil after soybean oil and palm oil, and it is therefore an important contributor to the annual supply of vegetable oils required to meet an increasing demand. This volume provides comprehensive coverage of rapeseed oil and its close relative, canola oil, from production (agronomic) aspects, through extraction to refining and processing. Chemical composition, physico--chemical properties, food and non--food uses are considered in detail, and a chapter is included on future prospects, including oils available by means of genetic manipulation. This is a book for oils and fats chemists and technologists in the food and oleochemical industries, chemical engineers in the processing industry, nutritionists and seed technologists.
The objective of this book is to provide the fundamental comprehension of a broad range of topics in an integrated volume such that readership hailing from diverse disciplines can rapidly acquire the necessary background for applying it in pertinent research and development field.
What Went Wrong? 6th Edition provides a complete analysis of the design, operational, and management causes of process plant accidents and disasters. Co-author Paul Amyotte has built on Trevor Kletz's legacy by incorporating questions and personal exercises at the end of each major book section. Case histories illustrate what went wrong and why it went wrong, and then guide readers in how to avoid similar tragedies and learn without having to experience the loss incurred by others. Updated throughout and expanded, this sixth edition is the ultimate resource of experienced-based analysis and guidance for safety and loss prevention professionals.
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