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European Pharmacopoeia 2012 Supplement 76 W 77 And 78 When Available
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Book Synopsis European Pharmacopoeia 2012: Supplement 7.3 W/ 7.4 and 7.5 When Available by : European Pharmacopoeia
Download or read book European Pharmacopoeia 2012: Supplement 7.3 W/ 7.4 and 7.5 When Available written by European Pharmacopoeia and published by . This book was released on 2011-08-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Nutraceuticals and Human Health by : Paul A Spagnuolo
Download or read book Nutraceuticals and Human Health written by Paul A Spagnuolo and published by Royal Society of Chemistry. This book was released on 2020-03-17 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nutraceuticals is a broad umbrella term used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. This book is a comprehensive look at two themes in the area: technical and biological considerations. Technical considerations include an in-depth look at the process of bioactive identification and extraction and factors controlling bioactive concentrations in food. It also includes details of how these products are regulated and the steps necessary to utilize these products in human populations. Biological considerations include looking at how these products can be used in the prevention and treatment of chronic diseases, and a discussion on the process of formulations and how these influence bioavailability. This will be the first book to comprehensively examine the entire process of nutraceutical development from food to supplement creation and all the important considerations in between. This serves as an excellent and up-to-date reference for food scientists, food chemists, researchers in nutraceuticals and human nutrition.
Download or read book The Bad Bug Book written by FDA and published by Imp. This book was released on 2004 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Bad Bug was created from the materials assembled at the FDA website of the same name. This handbook provides basic facts regarding foodborne pathogenic microorganisms and natural toxins. It brings together in one place information from the Food & Drug Administration, the Centers for Disease Control & Prevention, the USDA Food Safety Inspection Service, and the National Institutes of Health.
Book Synopsis Mutagenic Impurities by : Andrew Teasdale
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bad Bug Book written by Mark Walderhaug and published by Createspace Independent Publishing Platform. This book was released on 2014-01-14 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services.
Book Synopsis Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids by : Institute of Medicine
Download or read book Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids written by Institute of Medicine and published by National Academies Press. This book was released on 2000-08-27 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is the newest release in the authoritative series of quantitative estimates of nutrient intakes to be used for planning and assessing diets for healthy people. Dietary Reference Intakes (DRIs) is the newest framework for an expanded approach developed by U.S. and Canadian scientists. This book discusses in detail the role of vitamin C, vitamin E, selenium, and the carotenoids in human physiology and health. For each nutrient the committee presents what is known about how it functions in the human body, which factors may affect how it works, and how the nutrient may be related to chronic disease. Dietary Reference Intakes provides reference intakes, such as Recommended Dietary Allowances (RDAs), for use in planning nutritionally adequate diets for different groups based on age and gender, along with a new reference intake, the Tolerable Upper Intake Level (UL), designed to assist an individual in knowing how much is "too much" of a nutrient.
Book Synopsis Handbook of Pharmaceutical Excipients by : Raymond C. Rowe
Download or read book Handbook of Pharmaceutical Excipients written by Raymond C. Rowe and published by Amer Pharmacists Assn. This book was released on 2009-01-01 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.
Book Synopsis Standard Methods for the Examination of Water and Wastewater by : American Public Health Association
Download or read book Standard Methods for the Examination of Water and Wastewater written by American Public Health Association and published by . This book was released on 1981 with total page 1254 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (31 download)
Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis British Pharmacopoeia 2021 [print Edition] by : British Pharmacopoeia Commission
Download or read book British Pharmacopoeia 2021 [print Edition] written by British Pharmacopoeia Commission and published by . This book was released on 2020-07-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated annually, the British Pharmacopoeia (BP) is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. It includes approximately 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012. Where a BP monograph exists, medicinal products or active pharmaceutical ingredients sold or supplied in the UK must comply with the relevant monograph.All monographs and requirements of the European Pharmacopoeia (Ph. Eur.) are reproduced in the BP, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond.
Book Synopsis Specification of Drug Substances and Products by : Christopher M. Riley
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2024-09-22 with total page 910 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products - Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. - Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).
Book Synopsis Nutrient Requirements of Poultry by : National Research Council
Download or read book Nutrient Requirements of Poultry written by National Research Council and published by National Academies Press. This book was released on 1994-02-01 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference for poultry nutrition has been updated for the first time since 1984. The chapter on general considerations concerning individual nutrients and water has been greatly expanded and includes, for the first time, equations for predicting the energy value of individual feed ingredients from their proximate composition. This volume includes the latest information on the nutrient requirements of meat- and egg-type chickens, incorporating data on brown-egg strains, turkeys, geese, ducks, pheasants, Japanese quail, and Bobwhite quail. This publication also contains new appendix tables that document in detail the scientific information used to derive the nutrient requirements appearing in the summary tables for each species of bird.
Book Synopsis Historical Painting Techniques, Materials, and Studio Practice by : Arie Wallert
Download or read book Historical Painting Techniques, Materials, and Studio Practice written by Arie Wallert and published by Getty Publications. This book was released on 1995-08-24 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bridging the fields of conservation, art history, and museum curating, this volume contains the principal papers from an international symposium titled "Historical Painting Techniques, Materials, and Studio Practice" at the University of Leiden in Amsterdam, Netherlands, from June 26 to 29, 1995. The symposium—designed for art historians, conservators, conservation scientists, and museum curators worldwide—was organized by the Department of Art History at the University of Leiden and the Art History Department of the Central Research Laboratory for Objects of Art and Science in Amsterdam. Twenty-five contributors representing museums and conservation institutions throughout the world provide recent research on historical painting techniques, including wall painting and polychrome sculpture. Topics cover the latest art historical research and scientific analyses of original techniques and materials, as well as historical sources, such as medieval treatises and descriptions of painting techniques in historical literature. Chapters include the painting methods of Rembrandt and Vermeer, Dutch 17th-century landscape painting, wall paintings in English churches, Chinese paintings on paper and canvas, and Tibetan thangkas. Color plates and black-and-white photographs illustrate works from the Middle Ages to the 20th century.
Book Synopsis The Social Construction of Technological Systems by : Wiebe E. Bijker
Download or read book The Social Construction of Technological Systems written by Wiebe E. Bijker and published by MIT Press. This book was released on 1989 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The impact of technology on society is clear and unmistakeable. The influence of society on technology is more subtle. The 13 essays in this book have been written by a diverse group of scholars united by a common interest in creating a new field - the sociology of technology. They draw on a wide array of case studies - from cooking stoves to missile systems, from 15th-century Portugal to today's Al labs - to outline an original research program based on a synthesis of ideas from the social studies of science and the history of technology. Together they affirm the need for a study of technology that gives equal weight to technical, social, economic, and political questions"--Back cover.
Book Synopsis Extractables and Leachables by : Dennis Jenke
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Vitamin and Mineral Requirements in Human Nutrition by : World Health Organization
Download or read book Vitamin and Mineral Requirements in Human Nutrition written by World Health Organization and published by World Health Organization. This book was released on 2004 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 20 years micronutrients have assumed great public health importance and a considerable amount of research has lead to increasing knowledge of their physiological role. Because it is a rapidly developing field, the WHO and FAO convened an Expert Consultation to evaluate the current state of knowledge. It had three main tasks: to review the full scope of vitamin and minerals requirements; to draft and adopt a report which would provide recommended nutrient intakes for vitamins A, C, D, E, and K; the B vitamins; calcium; iron; magnesium; zinc; selenium; and iodine; to identify key issues for future research and make preliminary recommendations for the handbook. This report contains the outcome of the Consultation, combined with up-to-date evidence that has since become available.
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