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European Pharmacopoeia 2015 Supplement 83 W 84 And 85 When Available
Download European Pharmacopoeia 2015 Supplement 83 W 84 And 85 When Available full books in PDF, epub, and Kindle. Read online European Pharmacopoeia 2015 Supplement 83 W 84 And 85 When Available ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis European Pharmacopoeia 2015: Supplement 8.3 W/ 8.4 and 8.5 When Available by : European Pharmacopoeia
Download or read book European Pharmacopoeia 2015: Supplement 8.3 W/ 8.4 and 8.5 When Available written by European Pharmacopoeia and published by Worldwide Book Service. This book was released on 2014-07-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Tolerable upper intake levels for vitamins and minerals by : European Commission. Scientific Committee on Food
Download or read book Tolerable upper intake levels for vitamins and minerals written by European Commission. Scientific Committee on Food and published by . This book was released on 2006 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Pharmaceutical Salts Properties, Selection, and Use by : P. Heinrich Stahl
Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.
Book Synopsis Handbook of Essential Oils by : K. Husnu Can Baser
Download or read book Handbook of Essential Oils written by K. Husnu Can Baser and published by CRC Press. This book was released on 2009-12-28 with total page 994 pages. Available in PDF, EPUB and Kindle. Book excerpt: Egyptian hieroglyphs, Chinese scrolls, and Ayurvedic literature record physicians administering aromatic oils to their patients. Today society looks to science to document health choices and the oils do not disappoint. The growing body of evidence of their efficacy for more than just scenting a room underscores the need for production standards, quality control parameters for raw materials and finished products, and well-defined Good Manufacturing Practices. Edited by two renowned experts, the Handbook of Essential Oils covers all aspects of essential oils from chemistry, pharmacology, and biological activity, to production and trade, to uses and regulation. Bringing together significant research and market profiles, this comprehensive handbook provides a much-needed compilation of information related to the development, use, and marketing of essential oils, including their chemistry and biochemistry. A select group of authoritative experts explores the historical, biological, regulatory, and microbial aspects. This reference also covers sources, production, analysis, storage, and transport of oils as well as aromatherapy, pharmacology, toxicology, and metabolism. It includes discussions of biological activity testing, results of antimicrobial and antioxidant tests, and penetration-enhancing activities useful in drug delivery. New information on essential oils may lead to an increased understanding of their multidimensional uses and better, more ecologically friendly production methods. Reflecting the immense developments in scientific knowledge available on essential oils, this book brings multidisciplinary coverage of essential oils into one all-inclusive resource.
Book Synopsis WHO Monographs on Selected Medicinal Plants by : World Health Organization
Download or read book WHO Monographs on Selected Medicinal Plants written by World Health Organization and published by World Health Organization. This book was released on 1999 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second volume in a series of monographs which are intended to promote information exchange and international harmonised standards for the quality control and use of herbal medicines. It contains scientific information on 30 selected plants, and each entry includes a pharmacopoeial summary for quality assurance purposes, information on its clinical application and sections on contraindications, pharmacology, safety issues, and dosage forms. It provides two cumulative indexes with entries in alphabetical order by plant name and according to the plant material of interest.
Author :United States Food and Drug Administration Publisher :Createspace Independent Publishing Platform ISBN 13 :9781976578670 Total Pages :92 pages Book Rating :4.5/5 (786 download)
Book Synopsis Pharmaceutical Microbiology Manual by : United States Food and Drug Administration
Download or read book Pharmaceutical Microbiology Manual written by United States Food and Drug Administration and published by Createspace Independent Publishing Platform. This book was released on 2017-09-21 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by : World Health Organization
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by WHO Technical Report. This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: - WHO guidelines on good herbal processing practices for herbal medicines; - Guidelines on good manufacturing practices for the manufacture of herbal medicines; - Considerations for requesting analysis of medicine samples; - WHO model certificate of analysis; - WHO guidance on testing of "suspect" falsified medicines; - Good pharmacopoeial practices - Chapter on monographs for compounded preparations; - Good pharmacopoeial practices - Chapter on monographs on herbal medicines; - Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products; - Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions; - Stability testing of active pharmaceutical ingredients and finished pharmaceutical products; and - Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities.
Book Synopsis Some Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene by :
Download or read book Some Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene written by and published by . This book was released on 2002 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 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.
Book Synopsis Pharmaceutical Microbiology by : Tim Sandle
Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios
Book Synopsis Comprehensive Biomaterials by : Paul Ducheyne
Download or read book Comprehensive Biomaterials written by Paul Ducheyne and published by Elsevier. This book was released on 2015-08-28 with total page 3659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive Biomaterials brings together the myriad facets of biomaterials into one, major series of six edited volumes that would cover the field of biomaterials in a major, extensive fashion: Volume 1: Metallic, Ceramic and Polymeric Biomaterials Volume 2: Biologically Inspired and Biomolecular Materials Volume 3: Methods of Analysis Volume 4: Biocompatibility, Surface Engineering, and Delivery Of Drugs, Genes and Other Molecules Volume 5: Tissue and Organ Engineering Volume 6: Biomaterials and Clinical Use Experts from around the world in hundreds of related biomaterials areas have contributed to this publication, resulting in a continuum of rich information appropriate for many audiences. The work addresses the current status of nearly all biomaterials in the field, their strengths and weaknesses, their future prospects, appropriate analytical methods and testing, device applications and performance, emerging candidate materials as competitors and disruptive technologies, and strategic insights for those entering and operational in diverse biomaterials applications, research and development, regulatory management, and commercial aspects. From the outset, the goal was to review materials in the context of medical devices and tissue properties, biocompatibility and surface analysis, tissue engineering and controlled release. It was also the intent both, to focus on material properties from the perspectives of therapeutic and diagnostic use, and to address questions relevant to state-of-the-art research endeavors. Reviews the current status of nearly all biomaterials in the field by analyzing their strengths and weaknesses, performance as well as future prospects Presents appropriate analytical methods and testing procedures in addition to potential device applications Provides strategic insights for those working on diverse application areas such as R&D, regulatory management, and commercial development
Book Synopsis Peptide Therapeutics by : Ved Srivastava
Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
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.
Book Synopsis USP 33 NF 28 by : United States Pharmacopeial Convention
Download or read book USP 33 NF 28 written by United States Pharmacopeial Convention and published by . This book was released on 2010 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
