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Book ICH Quality Guidelines

    Book Details:
  • Author : Andrew Teasdale
  • Publisher : John Wiley & Sons
  • Release : 2017-09-29
  • ISBN : 1118971132
  • Pages : 624 pages

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Book Treatment of Micropollutants in Water and Wastewater

Download or read book Treatment of Micropollutants in Water and Wastewater written by Jurate Virkutyte and published by IWA Publishing. This book was released on 2010-08-14 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last few years there has been a growing concern over the increasing concentration of micropollutants originating from a great variety of sources including pharmaceutical, chemical engineering and personal care product industries in rivers, lakes, soil and groundwater. As most of the micropollutants are polar and persistent compounds, they are only partially or not at all removed from wastewater and thus can enter the environment posing a great risk to the biota. It is hypothesized that wastewater is one of the most important point sources for micropollutants. Treatment of Micropollutants in Water and Wastewater gives a comprehensive overview of modern analytical methods and will summarize novel single and hybrid methods to remove continuously emerging contaminants - micropollutants from the aqueous phase. New trends (e.g. sensor technology, nanotechnology and hybrid treatment technologies) are described in detail. The book is very timely because the new techniques are still in the development phase and have to be realized not only in the laboratory but also on a larger scale. The content of the book is divided into chapters that present current descriptive and analytical methods that are available to detect and measure micropollutants together with detailed information on various chemical, biological and physicochemical methods that have evolved over the last few decades. Treatment of Micropollutants in Water and Wastewater will also enable readers to make well informed choices through providing an understanding of why and how micropollutants must be removed from water sources, and what are the most appropriate and available techniques for providing a cost and technologically effective and sustainable solutions for reaching the goal of micropollutant-free water and wastewater. The book will be suitable for water and wastewater professionals as well for students and researchers in civil engineering, environmental engineering and process engineering fields.

Book Generalized Additive Models

Download or read book Generalized Additive Models written by T.J. Hastie and published by Routledge. This book was released on 2017-10-19 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes an array of power tools for data analysis that are based on nonparametric regression and smoothing techniques. These methods relax the linear assumption of many standard models and allow analysts to uncover structure in the data that might otherwise have been missed. While McCullagh and Nelder's Generalized Linear Models shows how to extend the usual linear methodology to cover analysis of a range of data types, Generalized Additive Models enhances this methodology even further by incorporating the flexibility of nonparametric regression. Clear prose, exercises in each chapter, and case studies enhance this popular text.

Book Mass Spectrometry Based Lipidomics

Download or read book Mass Spectrometry Based Lipidomics written by Fong-Fu Hsu and published by Humana. This book was released on 2021-05-29 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: This detailed volume covers conventional MS-based “shotgun lipidomics” by which samples are introduced by infusion or loop injection, as well as LC-MS-based lipidomics, which are becoming increasingly important due to the ever-increasing demand for a complete and precise lipid analysis of the complex and diversified lipids in nature. The volume features protocols applying chemical reactions, the on-line photochemical reactions combined with various MS methods for comprehensive characterization of various lipid classes, and quantification of specific and rare lipids. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Mass Spectrometry-Based Lipidomics: Methods and Protocols serves as an invaluable guide for biochemists and mass spectroscopists who are interested in lipid studies.

Book Robotics  Machinery and Engineering Technology for Precision Agriculture

Download or read book Robotics Machinery and Engineering Technology for Precision Agriculture written by Mark Shamtsyan and published by Springer Nature. This book was released on 2021-10-04 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a collection of papers presented at XIV International Scientific Conference “INTERAGROMASH 2021”, held at Don State Technical University, Rostov-on-Don, Russia, during 24–26 February 2021. The research results presented in this book cover applications of unmanned aerial systems, satellite-based applications for precision agriculture, proximal and remote sensing of soil and crop, spatial analysis, variable-rate technology, embedded sensing systems, drainage optimization and variable rate irrigation, wireless sensor networks, Internet of things, robotics, guidance and automation, software and mobile apps for precision agriculture, decision support for precision agriculture and data mining for precision agriculture.

Book Analytical Techniques in the Pharmaceutical Sciences

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Book Food Analysis Laboratory Manual

Download or read book Food Analysis Laboratory Manual written by S. Suzanne Nielsen and published by Springer Science & Business Media. This book was released on 2010-03-20 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition laboratory manual was written to accompany Food Analysis, Fourth Edition, ISBN 978-1-4419-1477-4, by the same author. The 21 laboratory exercises in the manual cover 20 of the 32 chapters in the textbook. Many of the laboratory exercises have multiple sections to cover several methods of analysis for a particular food component of characteristic. Most of the laboratory exercises include the following: introduction, reading assignment, objective, principle of method, chemicals, reagents, precautions and waste disposal, supplies, equipment, procedure, data and calculations, questions, and references. This laboratory manual is ideal for the laboratory portion of undergraduate courses in food analysis.

Book Trends in Bioelectroanalysis

Download or read book Trends in Bioelectroanalysis written by Frank-Michael Matysik and published by Springer. This book was released on 2016-11-08 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume offers a careful selection of trend-setting topics in the field. In-depth review articles illustrate current trends in the field. Experienced experts present a comprehensive overview concerning the electrochemical biosensing of glucose for diabetes care from an industrial research and development perspective a survey of bioassay applications for individually addressable electrochemical arrays, focusing on liquid-phase bioanalytical assays a review of recent advances in the development of electronic tongues based on the use of biosensor arrays coupled with advanced chemometric data analysis novel strategies of DNA biosensor development and corresponding applications for studies of DNA damage a survey of recent trends in the electrochemistry of redox proteins, including the increasing diversity of redox proteins used in electrochemical studies, novel immobilization strategies, and biosensor / biofuel cell applications an overview of electrochemical sensing of blood gases with advanced sensor concepts a survey of recent bioelectroanalytical studies with high spatial resolution using scanning electrochemical microscopy with a wide range of applications covering imaging of living cells, studies of metabolic activity, imaging of local enzyme activity, and studies of transport through biolayers This timely collection will be of interest not only for experts in the field, but also to students and their teachers in disciplines that include analytical chemistry, biology, electrochemistry, and various interdisciplinary research areas.

Book Microbiomes of the Built Environment

    Book Details:
  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release : 2017-10-06
  • ISBN : 0309449839
  • Pages : 318 pages

Download or read book Microbiomes of the Built Environment written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-06 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: People's desire to understand the environments in which they live is a natural one. People spend most of their time in spaces and structures designed, built, and managed by humans, and it is estimated that people in developed countries now spend 90 percent of their lives indoors. As people move from homes to workplaces, traveling in cars and on transit systems, microorganisms are continually with and around them. The human-associated microbes that are shed, along with the human behaviors that affect their transport and removal, make significant contributions to the diversity of the indoor microbiome. The characteristics of "healthy" indoor environments cannot yet be defined, nor do microbial, clinical, and building researchers yet understand how to modify features of indoor environmentsâ€"such as building ventilation systems and the chemistry of building materialsâ€"in ways that would have predictable impacts on microbial communities to promote health and prevent disease. The factors that affect the environments within buildings, the ways in which building characteristics influence the composition and function of indoor microbial communities, and the ways in which these microbial communities relate to human health and well-being are extraordinarily complex and can be explored only as a dynamic, interconnected ecosystem by engaging the fields of microbial biology and ecology, chemistry, building science, and human physiology. This report reviews what is known about the intersection of these disciplines, and how new tools may facilitate advances in understanding the ecosystem of built environments, indoor microbiomes, and effects on human health and well-being. It offers a research agenda to generate the information needed so that stakeholders with an interest in understanding the impacts of built environments will be able to make more informed decisions.

Book The Advanced Theory of Statistics

Download or read book The Advanced Theory of Statistics written by Maurice George Kendall and published by . This book was released on 1963 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Clinical Chemistry

    Book Details:
  • Author : William J. Marshall
  • Publisher : Elsevier Health Sciences
  • Release : 2020-05-12
  • ISBN : 0702079316
  • Pages : 436 pages

Download or read book Clinical Chemistry written by William J. Marshall and published by Elsevier Health Sciences. This book was released on 2020-05-12 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Chemistry considers what happens to the body’s chemistry when affected by disease. It provides introductory coverage of the scientific basis for biochemistry tests routinely used in medicine - including tests for the assessment of organ function, diagnosis and monitoring disease activity and therapy efficacy. Each topic area begins with a concise description of the underlying physiological and biochemical principles and then applies them to patient investigation and management. The regular use of case histories helps further emphasise clinical relevance and chapter key points, as well as provide a useful starting point for examination revision. The clear and engaging writing style appreciated by generations of readers has been retained in this ninth edition, while the content has been thoroughly updated throughout. The approach and scope of this trusted text makes it ideal for integrated medical curricula, for medical training and for students and practitioners of clinical and biomedical science. The complementary eBook version, including additional cases and self-assessment material, completes this superb learning package. Updated to incorporate the latest changes in practice – including new tests and the most recent evidence-based guidance – plus a new chapter on clinical chemistry in pediatrics. Figures, tables, boxes, and case studies aid understanding and learning. ‘Light bulb’ sections give practical advice and clarify difficult concepts or potential pitfalls. New ‘Red flag’ boxes highlight the results which should cause immediate concern to clinicians. Updated references to core guidelines reflect latest best practice.

Book Biofilms in Medicine  Industry and Environmental Biotechnology

Download or read book Biofilms in Medicine Industry and Environmental Biotechnology written by Piet Lens and published by IWA Publishing. This book was released on 2003-04-30 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biofilms are of great practical importance for beneficial technologies such as water and wastewater treatment and bioremediation of groundwater and soil. In other settings biofilms cause severe problems, for example in 65% of bacterial infections currently treated by clinicians (particularly those associated with prosthetics and implants), accelerated corrosion in industrial systems, oil souring and biofouling. Until recently, the structure and function of biofilms could only be inferred from gross measures of biomass and metabolic activity. This limitation meant that investigators involved in biofilm research and application had only a crude understanding of the microbial ecology, physical structure and chemical characteristics of biofilms. Consequently, opportunities for the exploitation and control of biofilms were very limited. The past decade has witnessed the development of several new techniques to elucidate the structure and function of biofilms. Examples include: the use of molecular probes that identify different microbes in complex communities as well as their metabolic functions; the use of microsensors that show concentration gradients of key nutrients and chemicals; the use of confocal laser scanning microscopy to describe the physical structure of biofilms and the development of a new generation of mathematical models that allow for the prediction of biofilm structure and function. However, much progress remains to be made in efforts to understand, control and exploit biofilms. This timely book will introduce its readers to the structure and function of biofilms at a fundamental level as determined during the past decade of research, including: Extracellular polymers as the biofilm matrix; Biofilm phenotype (differential gene expression, interspecies signalling); Biofilm ecology; Biofilm monitoring; Resistance of biofilms to antimicrobial agents and Biofilm abatement. Biofilms in Medicine, Industry and Environmental Technology offers a holistic and multi-disciplinary description of the topic, including biofilm formation and composition, but also biofilm monitoring, disinfection and control. All these aspects are presented from three points of views: medical, industrial and environmental biotechnological in a compact, easy to read format.

Book Handbook of Food Chemistry

Download or read book Handbook of Food Chemistry written by Peter Chi Keung Cheung and published by Springer. This book was released on 2015-10-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is intended to be a comprehensive reference for the various chemical aspects of foods and food products. Apart from the traditional knowledge, this book covers the most recent research and development of food chemistry in the areas of functional foods and nutraceuticals, organic and genetically modified foods, nonthermal food processing as well as nanotechnology. This handbook contains both the basic and advanced chemistry both for food research and its practical applications in various food related industries and businesses. This book is appropriate for undergraduates and postgraduates in the academics and professionals from the various disciplines and industries who are interested in applying knowledge of food chemistry in their respective fields.

Book Waste Biorefineries  Future Energy  Green Products and Waste Treatment

Download or read book Waste Biorefineries Future Energy Green Products and Waste Treatment written by Mohammad Rehan and published by Frontiers Media SA. This book was released on 2019-09-24 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Energy recovery from waste resources holds a significant role in the sustainable waste management hierarchy to support the concept of circular economies and to mitigate the challenges of waste originated problems of sanitation, environment, and public health. Today, waste disposal to landfills is the most widely used methodology, particularly in developing countries, because of limited budgets and lack of efficient infrastructure and facilities to maintain efficient and practical global standards. As a consequence, the dump-sites or non-sanitary landfills have become the significant sources of greenhouse gases emissions, soil and water contamination, unpleasant odors, leachate, and disease spreading vectors, flies, and rodents. However, waste can be utilized to produce a range of potential products such as energy, fuels and value-added products under waste biorefineries. A holistic and quantitative view, such as waste biorefinery, on waste management must be linked to the actual country, taking into account its socio-economic situation, local waste sources, and composition, as well as the available markets for the recovered energy and products. Therefore, it is critical to understand that solutions cannot be just copied from one region to the others. In fact, all waste handling, transportation, and treatment can represent a burden to the cities’ environment and macro and micro economics, except for the benefits obtained from recovered materials and energy. Equally significant is a clear and quantitative understanding of the industrial, and public potential of utilizing recovered materials and energy in the markets as these can be reached without exacerbating the environmental issues using excessive transport. The book explores new advancements and discoveries on the development of emerging waste-to-energy technologies, practical implementation, and lessons learned from sustainable wastemanagement practices under waste biorefinery concept, which will accelerate the growth of circular economies in the world. The articles presented in this book have been written by expert researchers and academics working in institutions at different countries across the world including Germany, Greece, Japan, South Korea, China, Saudi Arabia, Pakistan, Indonesia, Malaysia, Iran, and India. The research articles have been arranged into three main subject categories; 1) Resource recovery from waste, 2) Waste to energy technologies and 3) Waste biorefineries. This book will serve as an important resource for research students, academics, industry, policy makers, and government agencies working in the field of integrated waste management, energy and resource recovery, waste to energy technologies, waste biorefineries etc. The editorial team of this book is very grateful to all the authors for their excellent contributions and making the book successful.

Book Soil and Sediment Remediation

Download or read book Soil and Sediment Remediation written by Piet Lens and published by IWA Publishing. This book was released on 2005-09-30 with total page 545 pages. Available in PDF, EPUB and Kindle. Book excerpt: Soil and Sediment Remediation discusses in detail a whole set of remediative technologies currently available to minimise their impact. Technologies for the treatment of soils and sediments in-situ (landfarming, bioscreens, bioventing, nutrient injection, phytoremediation) and ex-situ (landfarming, bio-heap treatment, soil suspension reactor) will be discussed. The microbiological, process technological and socio-economical aspects of these technologies will be addressed. Special attention will be given to novel biotechnological processes that utilise sulfur cycle conversions, e.g. sulfur and heavy metal removal from soils. Also the potential of phytoremediation will be highlighted. In addition, treatment schemes for the clean-up of polluted megasites, e.g. harbours and Manufactured Gaswork Plants (MGP), will be elaborated. The aim of Soil and Sediment Remediation is to introduce the reader in: the biogeochemical characteristics of soil and sediments- new techniques to study soil/sediment processes (molecular probes, microelectrodes, NMR) clean up technologies for soils polluted with organic (PAH, NAPL, solvents) or inorganic (heavy metals) pollutants- preventative and remediative strategies and technologies available in environmental engineering novel process applications and bioreactor designs for bioremediation the impact of soil pollution on society and its economic importance.

Book Physical Properties of Lipids

Download or read book Physical Properties of Lipids written by Alejandro G. Marangoni and published by CRC Press. This book was released on 2002-03-04 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides in-depth coverage of the physical properties of fats and oils. Includes surface and theological characteristics as well as crystallization and phase behavior for improved nutrition and functionality in the design of new food products.

Book Tuberculosis Drug Discovery and Development 2019

Download or read book Tuberculosis Drug Discovery and Development 2019 written by Giovanna Riccardi and published by MDPI. This book was released on 2020-11-24 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis and still represents one of the global health threats to mankind. The World Health Organization estimated more than 10 million new cases and reported more than 1.5 million deaths in 2019, thus ranking TB among the main causes of death due to a single pathogen. Standard anti-TB therapy includes four first-line antibiotics that should be administered for at least six months. However, in the case of multi- and extensively drug-resistant TB, second-line medications must be used and these frequently cause severe side effects resulting in poor compliance. Developing new anti-TB drug candidates is therefore of outmost importance. In this Special Issue dedicated to Tuberculosis Drug Discovery and Development, we present the main and latest achievements in the fields of drug and target discovery, host-directed therapy, anti-virulence drugs, and describe the development of two advanced compounds: macozinone and delpazolid. In addition, this Special Issue provides an historical perspective focused on Carlo Forlanini, the inventor of pneumothorax for TB treatment, and includes an overview of the state-of-the-art technologies which are being exploited nowadays in TB drug development. Finally, a summary of TB vaccines that are either approved or undergoing clinical trials concludes the Special Issue.