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Validation of Bioanalytical Methods (essentials)
by Patric U. Vogelthis book, the validation of bioanalytical methods is described. In the quality control of biological medicinal products, bioanalytical methods are frequently used to check important properties such as the content or possible impurities. The methods used must provide trustworthy results so that no false conclusions are drawn when evaluating the results. The trustworthiness is ensured by validation. The validation of bioanalytical methods is illustrated by means of some examples.
Validation of Computerized Analytical Systems
by Ludwig HuberValidation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
by Syed Imtiaz HaiderSpanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Validierung (essentials)
by Patric U. VogelIn diesem Buch wird die Validierung analytischer Methoden beschrieben. Bei der Qualitätskontrolle von biologischen Arzneimitteln kommen häufig biologisch-analytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mögliche Verunreinigungen zu überprüfen. Die eingesetzten Methoden müssen vertrauenswürdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlüsse gezogen werden. Die Vertrauenswürdigkeit wird durch eine Validierung sichergestellt. Die Validierung von analytischen Methoden wird anhand einiger Beispiele dargestellt. Die geänderten Vorgaben ab Juni 2024 sind berücksichtigt.
Validierung bioanalytischer Methoden (essentials)
by Patric U. VogelIn diesem Buch wird die Validierung bioanalytischer Methoden beschrieben. Bei der Qualitätskontrolle von biologischen Arzneimitteln kommen häufig bioanalytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mögliche Verunreinigungen zu überprüfen. Die eingesetzten Methoden müssen vertrauenswürdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlüsse gezogen werden. Die Vertrauenswürdigkeit wird durch eine Validierung sichergestellt. Die Validierung von bioanalytischen Methoden wird anhand einiger Beispiele dargestellt.
Validierung in der Analytik (Die Praxis der instrumentellen Analytik)
by Stavros KromidasDie Validierung von Methoden und Geräten ist eine elementare Aufgabe in jedem analytischen Labor. Erstmals liegt mit diesem Band der Reihe eine praktische Einführung für den Anwender vor. In didaktisch bewährter Form werden die einzelnen Validierungsparameter ausführlich erklärt, kommentiert und ihre Verknüpfung erläutert. Der Leser wird sukzessiv durch die Validierungsschritte geführt, von der Fragestellung bis zur Bewertung der Ergebnisse und Plausibilitätsbetrachtung. Er erhält konkrete Hilfestellung in Form von Fallbeispielen, Checklisten und Diagrammen sowie durch Antworten auf typische Fragen und Hinweise zur Vermeidung typischer Fehler. Ergänzend dazu enthält das Buch ein Glossar und einen Anhang mit nützlichen weiterführenden Informationen. Es ist der Begleiter für alle Anwender, die validieren müssen. Aus Rezensionen bereits erschienener Bände: 'Das sehr empfehlenswerte Werk ist didaktisch geschickt formuliert und illustriert [...]. Es setzt die bewährte Reihe zur Praxis der instrumentellen Analytik fort und sollte in keiner einschlägigen Fachbibliothek fehlen.' (Die Pharmazeutische Industrie) 'Besonders lehrreich für den Anfänger ist die Vielzahl von praktischen Beispielen' (Die Nahrung)
Validity Assessment in Clinical Neuropsychological Practice: Evaluating and Managing Noncredible Performance (Evidence-Based Practice in Neuropsychology)
by Ryan W. Schroeder and Phillip K. MartinPractical and comprehensive, this is the first book to focus on noncredible performance in clinical contexts. Experts in the field discuss the varied causes of invalidity, describe how to efficiently incorporate validity tests into clinical evaluations, and provide direction on how to proceed when noncredible responding is detected. Thoughtful, ethical guidance is given for offering patient feedback and writing effective reports. Population-specific chapters cover validity assessment with military personnel; children; and individuals with dementia, psychiatric disorders, mild traumatic brain injury, academic disability, and other concerns. The concluding chapter describes how to appropriately engage in legal proceedings if a clinical case becomes forensic. Case examples and sample reports enhance the book's utility.
Valley of Forgetting: Alzheimer's Families and the Search for a Cure
by null Jennie Erin SmithThe riveting account of a community from the remote mountains of Colombia whose rare and fatal genetic mutation is unlocking the secrets of Alzheimer&’s disease&“Powerful. . . . a poignant depiction of a community in crisis.&” —Publishers WeeklyIn the 1980s, a neurologist named Francisco Lopera traveled on horseback into the mountains seeking families with symptoms of dementia. For centuries, residents of certain villages near Medellín had suffered memory loss as they reached middle age, going on to die in their fifties. Lopera discovered that a unique genetic mutation was causing their rare hereditary form of early onset Alzheimer&’s disease. Over the next forty years of working with the &“paisa mutation&” kindred, he went on to build a world-class research program in a region beset by violence and poverty.In Valley of Forgetting, Jennie Erin Smith brings readers into the clinic, the laboratories, and the Medellín trial center where Lopera&’s patients receive an experimental drug to see if Alzheimer&’s can be averted. She chronicles the lives of people who care for sick parents, spouses, and siblings, all while struggling to keep their own dreams afloat. These Colombian families have donated hundreds of their loved ones&’ brains to science and subjected themselves to invasive testing to help uncover how Alzheimer&’s develops and whether it can be stopped. Findings from this unprecedented effort could hold the key to understanding and treating the disease, though it is unclear what, if anything, the families will receive in return.Smith&’s immersive storytelling brings this complex drama to life, inviting readers on a scientific journey that is as deeply moving as it is engrossing.
Valorisation of Agro-industrial Residues – Volume I: Biological Approaches (Applied Environmental Science and Engineering for a Sustainable Future)
by Zainul Akmar Zakaria Ramaraj Boopathy Julian Rafael DibAgriculture and industry are the two most important economic sectors for various countries around the globe, providing millions of jobs as well as being the main source of income for these countries. Nevertheless, with the increasing demand for agricultural and industrial produce, huge amounts of waste are also being produced. Without proper management, this waste (both liquid and solid) poses a serious threat to overall environmental quality, mainly due to its toxicity and slow degradation processes. Current approaches are effective but would normally require huge capital investments, are labour intensive and generate potential hazardous by-products. As such, there is a need for alternative approaches that are cheaper, easier-to-handle and have a minimum potential impact on environmental quality. This book presents up-to-date approaches using biological techniques to manage the abundance of waste generated from agricultural and industrial activities. It discusses techniques such as bioconversion, biodegradation, biotransformation, and biomonitoring as well as the utilization of these wastes. A number of chapters also include individual case studies to enhance readers’ understanding of the topics. This comprehensive book is a useful resource for anyone involved in agricultural and industrial waste management, green chemistry or biotechnology. It is also recommended as a reference work for graduate students and all agriculture and biotechnology libraries.
Valorisation of Agro-industrial Residues – Volume II: Non-Biological Approaches (Applied Environmental Science and Engineering for a Sustainable Future)
by Zainul Akmar Zakaria Cristobal N Aguilar Ratna Dewi Kusumaningtyas Parameswaran BinodThe world’s population is expected to reach the eight billion mark very soon. As a result, there is a need for increased industrial and agricultural production to ensure human wellbeing. This in turn generates huge amounts of waste. Current waste treatment solutions are effective, but usually require huge capital investment, are labour intensive and potentially lead to hazardous by-products. This book presents the latest non-biological approaches to address issues related to the abundance of waste, offering insights into best practices in various regions around the globe. It highlights techniques such as chemical extraction, pyrolysis and ultrasonics, and a number of chapters include individual case studies to further enhance readers’ understanding. This comprehensive reference resource is intended for graduate students, researchers and scientists, and is also a valuable addition to all agriculture and biotechnology libraries.
Valorisation of Waste and Secondary Materials for Roads: State-of-the-Art Report of the RILEM TC 279-WMR (RILEM State-of-the-Art Reports #38)
by Augusto Cannone Falchetto Lily Poulikakos Emiliano Pasquini Di WangThis book presents the work of the RILEM TC 279-WMR, whose purpose was to facilitate the use of waste, marginal and secondary materials for roads by investigating the performance of road materials containing waste through round robin tests and the development of standard procedures for their selection, preparation, and use. The structure of this book includes an introduction, five technical chapters, and a conclusion. The topics addressed are: the use of asphalt binder additives such as plastic and rubber; the combined use of aggregate and filler substitute in paving mixtures (construction demolition waste, rubber, and steel slags); the environmental assessment and the potential sources of pollutants originated from the use of this recycled materials.
Valorization of Agro-Industrial Byproducts: Sustainable Approaches for Industrial Transformation
by Anil Kumar Anal and Parmjit S. PanesarThis book covers sustainable approaches for industrial transformation pertaining to valorization of agro-industrial byproducts. Divided into four sections, it starts with information about the agro/food industry and its byproducts, including their characterization, followed by different green technologies (principle, process strategies and extraction of bioactive compounds) applied for the management of agro industry byproducts. It further explains biotechnological interventions involved in the value addition of these byproducts. Various regulatory and environmental concerns related to by-product management along with biorefinery concept and future strategies are provided as well. Features: Provides extensive coverage of agro-industrial by products and their environmental impact. Details production of value-added products from agro-industrial waste. Describes environmental legislations and future strategies. Presents multidisciplinary approaches from fundamental to applied and addresses the biorefinery and circular economy. Includes innovative approaches and future strategies for management of agro-industrial waste. This book is aimed at researchers, graduate students and professionals in food science/food engineering, bioprocessing/biofuels/bioproducts/biochemicals and agriculture, bioeconomy, food waste processing, post-harvest processing, and waste management.
Valorization of Biomass to Value-Added Commodities: Current Trends, Challenges, and Future Prospects (Green Energy and Technology)
by Michael O. Daramola Augustine O. AyeniThis book presents the most up-to-date technologies for the transformation of biomass into valuable fuels, chemicals, materials, and products. It provides comprehensive coverage of the characterization and fractionation of various types of biomass and details the many challenges that are currently encountered during this process. Divided into two sections, this book discusses timely topics such as the characterization of biomass feedstock, pretreatment and fractionation of biomass, and describes the process for conversion of biomass to value-added commodities. The authors bring biomass transformational strategies that are yet to be explored to the forefront, making this innovative book useful for graduate students and researchers in academia, government, and industry.
Valorization of Biomass Wastes for Environmental Sustainability: Green Practices for the Rural Circular Economy
by Mukesh Kumar Arun Lal Srivastav Abhishek Kumar BhardwajThis volume discusses the reduction, recycling, and reuse of industrial and agricultural biomass wastes to develop value-added products using environmentally sustainable practices and technologies. Through these waste valorization approaches, biomass waste materials can be converted into useful bio-chemical products, sustainable construction materials, polymers, bio-energy, and bio-fuel as sustainable alternatives to products and materials with negative environmental and health consequences. The chapters highlight the development and implementation of eco-friendly solutions to biomass waste production with the aim of reducing natural resource deterioration, bolstering rural and small-scale business systems in communities impacted by pollution and climate change, and providing power from residual biomass to broadly reduce environmental impacts through improved waste management practices. The book is intended to be a useful resource for researchers, policymakers, NGOs, government agencies, and local community authorities working in waste management and environmental sustainability.
Valorization of Food Processing By-Products (Fermented Foods and Beverages Series)
by M. ChandrasekaranBiotechnology has immense potential for resolving environmental problems and augmenting food production. Particularly, it offers solutions for converting solid wastes into value-added items. In food processing industries that generate voluminous by-products and wastes, valorization can help offset growing environmental problems and facilitate the s
Valorization of Wine Making By-Products
by Matteo BordigaAn overview of wine making by-products and their conventional and non-conventional uses, Valorization of Wine Making By-Products gives you a deeper understanding of recovery processes that are a part of the new philosophy of sustainable agriculture. In line with the worldwide movement toward sustainable development, this book examines how to conver
Valuation and Sustainability: A Guide to Include Environmental, Social, and Governance Data in Business Valuation (Sustainable Finance)
by Dejan GlavasDo you want to know how to integrate environmental, social, and governance (ESG) data into business valuation? This book will help you do so step-by-step. The book primarily aims at reaching two types of audiences: practitioners and students in finance (graduate and undergraduate level). Practitioners in finance will find interest in the book, as it will give them access to academic knowledge in a format that suits them. Academic research has made substantial advances in the field of business valuation and ESG. The book intends to transform this knowledge into practical and rigorous methodologies for taking ESG into account when valuing a company. Graduate and undergraduate courses have recently developed in business schools, universities, and engineering schools. These courses usually directly refer to academic articles or valuation companies' website documentation, but not to academic books. Therefore, the book will allow students to have access to centralized and organized information about business valuation and ESG. Readers without prior knowledge of business valuation will be guided through the ESG integration process. They will first be introduced to the concept of value and the reasons for incorporating ESG into the value. They will then learn simple financial methods to value firms and see step-by-step use cases. For instance, the reader will learn how to value a firm in the renewable energy sector using cash flow and multiple valuation methods. After building knowledge of standard business valuation, readers will better understand ESG data and ratings. The reader will then learn how to integrate ESG into business valuation using cash flow and multiples approaches. Again, the reader will be able to replicate these methods as the book will provide practical cases for integrating ESG data in business valuation. Finally, for the readers that intend to go a bit further, they will learn about the academic research advances in ESG and business valuation.
Valuation of Ecological Resources: Integration of Ecology and Socioeconomics in Environmental Decision Making
by Ralph G. Stahl Jr. Lawrence A. Kapustka Wayne R. Munns Jr. Randall J. BruinsChoosing the optimal management option requires environmental risk managers and decision makers to evaluate diverse, and not always congruent, needs and interests of multiple stakeholders. Understanding the trade-offs of different options as well as their legal, economic, scientific, and technological implications is critical to performing accurate
Valuation of Network Effects in Software Markets: A Complex Networks Approach
by Andreas KemperThe customer base is an important value driver of software companies and a reliable prediction of its development is fundamental for investment decisions. A particularity in software markets is that an individual's purchasing decision is often influenced by other users' choices. Although such customer network effects are evident, their quantitative assessment remain elusive with conventional approaches. This book contributes to closing this gap by developing methods for measuring network effects and their implications for valuation in software markets. Based on the theory of complex networks the book reveals that such diffusion processes highly depend on structural properties of customer networks. Moreover, it depicts that such insights are contributions to improve the quality of valuations in software markets. But the implications of this research also comprise social and political aspects as they can be applied in order to prevent corporate failures in all network effect markets.
Value-Added Biocomposites: Technology, Innovation, and Opportunity
by Malinee Sriariyanun Sanjay Mavinkere Rangappa Suchart Siengchin Hom Nath DhakalValue-Added Biocomposites: Technology, Innovation, and Opportunity explores advances in research, processing, manufacturing, and novel applications of biocomposites. It describes the current market situation, commercial competition, and societal and economic impacts and advantages of substituting biocomposites for conventional composites, including natural fibers and bioplastics. FEATURES Discusses manufacturing and processing procedures that focus on improving physical, mechanical, thermal, electrical, chemical, and biological properties and achieving required specifications of downstream industries and customers Analyzes the wide range of available base materials and fillers of biocomposites and bioplastics in terms of the strength and weaknesses of materials and economic potential in the market Displays special and unique properties of biocomposites in different market sectors Showcases the insight of expert scientists and engineers with first-hand experience working with biocomposites across various industries Covers environmental factors, life cycle assessment, and waste recovery Combining technical, economic, and environmental topics, this work provides researchers, advanced students, and industry professionals a holistic overview of the value that biocomposites add across a variety of engineering applications and how to balance research and development with practical results.
Value-added Products from Algae: Phycochemical Production and Applications
by Abdelfatah Abomohra Stephan EndeThis book provides a comprehensive overview of value-added products from algae, presenting the fundamentals of algal cultivation, metabolism, harvest, and cellular pathways of phycochemicals biosynthesis. It offers sufficient details for both experts and non-experts to grasp the recent progress in this field. The book also discusses new phycochemicals and advancements in technology development, from separation to scale-up commercialization. Divided into 18 chapters, the book begins with an introduction to the value of algae as a renewable resource, followed by an authoritative overview of topics such as algae cultivation systems, harvesting techniques, phycochemical analysis, artificial intelligence in phytochemical recognition, and bioprocess engineering. Additional chapters cover various aspects of algal biotechnology, including biorefinery technology, biofuel-integrated routes, and the use of wastewater for algal growth. The book also explores high throughput screening methods for microalgae-based phycochemicals and examines the catalytic processes involved in algal bioprocessing. Cutting-edge topics such as omics approaches for algal applications, algal-based biopolymers, diatom nanostructured biosilica, and the potential of seaweeds in methane emission mitigation, are also explored. In this book, readers will discover the recent technological applications of algae in aquaculture and will find a case study on the functional food potential of Spirulina. Recognizing the importance of legislation and biosecurity in the field, the last chapter of the book addresses the regulatory frameworks and biosecurity measures necessary for the safe and sustainable development of algal biotechnology. Given its breadth, the book is a valuable resource for scholars, researchers and professionals interested in algal biotechnology, sustainability, biomass conversion, and new algal products from any perspective.
Value Added Products From Bioalgae Based Biorefineries: Opportunities and Challenges
by Shailendra Kumar Arya Madhu Khatri Gursharan SinghThis book covers wide aspects of algal technology and algae-based biorefinery aspects. Algae are the most prevalent, primitive, and abundant microbes on Earth, however, the commercialization of algal-based value-added products is still low due to the negligible dissemination of knowledge flow among the stakeholders and researchers.This book provides up-to-date information on the cultivation of microalgae, their harvesting, downstream processing, and diverse applications. It further discusses the macromolecules existing in microalgae, such as proteins, carbohydrates, and lipids, poly-unsaturated fatty acids, peptides, exo-polysaccharides, flavonoids and antioxidants. This book also highlights the advantages and some real-time challenges before the establishment of sustainable algal-based biorefineries. Further, it includes clear flow charts and figures in each chapter to aid in interpretation of every technical concept. This book motivates readers, entrepreneurs, and young farmers to exploit easily growing microalgae through cottage to large-scale biorefineries and start their own businesses for the production of value-added products.
Value Added Products From Food Waste
by Elsa Cherian Baskar GurunathanThe rapid increase in industrial processes for the preparation and processing of various food products have resulted in the creation of large quantities of waste. These food wastes contain large amounts of nutrients which can be further converted into useful products, making byproduct technology increasingly important.Byproducts produced from various agro-based industries like cereals, fruits, vegetable processing, fish, meat and poultry can be converted into beneficial products. For instance, cereal and legume processing produces large quantities of wastes which can result in environmental problems affecting air, soil and water quality. These wastes can be efficiently utilized and converted into value added products such as bioethanol, butanol, biohydrogen, biogas, biocoal, industrially treasured enzymes, biofertilizer, proteins and organic acids. Value Added Products From Food Waste covers waste management techniques utilized for managing raw materials in the food industry in an efficient way, recovering and reusing waste or neutralizing unwanted components. Chapters focus on the latest technologies and efficient management systems in all areas of food processing that make this process economical and minimize the hazards caused by the deposition of waste. From the dairy industry to cereals to fruits and vegetables to fish, each aspect of the food industry is examined with an eye for how to utilize food waste, transforming these wastes into value added products.
Value Addition and Product Diversification in Sugarcane
by Giriyapura Shivalingamurthy Suresha Gopalareddy Krishnappa Murali Palanichamy Huskur Kumaraswamy Mahadeva Swamy Hari Kuppusamy Hemaprabha GovindakurupThis contributed volume covers sugarcane byproducts, preservation, functional foods, bioethanol, and liquid fuels. It focuses on advancements in value addition and its applications in food and other industries, sugarcane biomass, and its utilization in the energy sector. Sugarcane production has been increasing for several decades; however, it has only recently gained importance for product diversification and bioenergy applications. The book also explores biopharming/molecular pharming, genomics for product diversification, biotechnological manipulations for bioenergy applications, metabolic engineering, bioenergy policy, economics, and market intelligence. This book provides an opportunity to compile recent technological advancements in value addition and product diversification, offering insights into the role of sugarcane in green fuels and global energy security in a sustainable manner. This book caters to the needs of various stakeholders, including students, researchers, policymakers, and academicians working in functional foods, nutraceutical research, bioenergy, and synthetic biology. It is also designed for personnel in the sugar and food industries, green fuels, chemical industries, and textile and recycling industries.
Value Addition and Utilization of Lignocellulosic Biomass: Through Novel Technological Interventions
by Gunjan Mukherjee Sunny DhimanThis book addresses the pressing global challenge of lignocellulosic biomass waste by exploring innovative technological solutions for its mitigation and conversion into valuable products. One of the key challenges faced is the effective management of lignocellulosic biomass waste generated from various industries, including agriculture, forestry, and food processing. The demand for sustainable solutions for lignocellulosic waste management is steadily increasing, driven by environmental concerns, government regulations, and the pursuit of circular economy principles. This book aims to delve into the innovative technological solutions driving these transformations. It provides valuable insights into the transformative potential of these approaches in lignocellulosic biomass waste mitigation and the transition towards a more sustainable environment. This book is a definitive resource for researchers, professionals, and policymakers engaged in the fields of lignocellulosic biomass valorisation, waste management, and sustainable development. The exploration of case studies, economic assessments, and policy perspectives will contribute to the body of knowledge in this critical field and facilitate the transition towards a more sustainable future.