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Quality Assurance Problem Solving And Training Strategies For Success In The Pharmaceutical And Life Science Industries
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Download or read book Quality Assurance written by Gordon Welty and published by . This book was released on 2013 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requiremen.
Download or read book Quality Assurance written by G Welty and published by Elsevier. This book was released on 2013-06-30 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. - Presents a comprehensive view of the field of quality assurance - An approach grounded in direct experience - Uses diagrams and figures to clarify analytical points
Book Synopsis An Introduction to Pharmaceutical Sciences by : Jiben Roy
Download or read book An Introduction to Pharmaceutical Sciences written by Jiben Roy and published by Elsevier. This book was released on 2011-07-25 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. - Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions - Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes - Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries
Book Synopsis Formulation Tools for Pharmaceutical Development by : J E Aguilar
Download or read book Formulation Tools for Pharmaceutical Development written by J E Aguilar and published by Elsevier. This book was released on 2013-09-30 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools.Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. - Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines - Development of drugs and medicines using mathematical tools - Compilation of expert system developed around the world
Book Synopsis Computer-Aided Applications in Pharmaceutical Technology by : Jelena Duris
Download or read book Computer-Aided Applications in Pharmaceutical Technology written by Jelena Duris and published by Elsevier. This book was released on 2013-04-10 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-Aided Applications in Pharmaceutical Technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications
Book Synopsis A Biotech Manager's Handbook by : M O'Neill
Download or read book A Biotech Manager's Handbook written by M O'Neill and published by Elsevier. This book was released on 2012-05-02 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. - No other 'how to' manual exists for this sector - Written by a range of expert professionals in each area, all in one book - Is the only 'bench to bedside' book covering the whole spectrum of development
Book Synopsis Bioinformatics for Biomedical Science and Clinical Applications by : K-H Liang
Download or read book Bioinformatics for Biomedical Science and Clinical Applications written by K-H Liang and published by Elsevier. This book was released on 2013-07-31 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications.Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical questions. The first two chapters consider Bioinformatics and analysis of the human genome. The subsequent three chapters cover the introduction of Transcriptomics, Proteomics and Systems biomedical science. The remaining chapters move on to critical developments, clinical information and conclude with domain knowledge and adaptivity. - A coherent presentation of concepts, methodologies and practical tools that systematically lead to significant discoveries in the biomedical and clinical area - Real examples of cutting edge discoveries - The introduction of study types and technologies for all the DNA, RNA and protein levels
Book Synopsis Commercializing the Stem Cell Sciences by : Olivia Harvey
Download or read book Commercializing the Stem Cell Sciences written by Olivia Harvey and published by Elsevier. This book was released on 2012-10-16 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promising new developments in biomedical technology such as stem cell science are widely endorsed by governments keen to reduce spiralling healthcare costs, clinicians focused on patient care, and patients demanding revolutionary new treatments. Commercializing the stem cell sciences offers a comparative analysis of the commercial methods adopted in the global stem cell industries. It seeks to establish whether there is an optimum commercial model and to examine what emerging companies can learn from their predecessors. Following an introduction to stem cell sciences and the problems involved in their commercialization, the book begins with a discussion of stem cell treatments from a global perspective, and the role of innovation in the commercialization of biotechnology in general. In the second half of the book, chapters focus on the different strategies that can be employed and their relative risks and values, before a conclusion that looks at potential new developments in the field. - In-depth discussion of case studies of products undergoing development - Focus on commercial optimization of stem cell treatments - Analysis in a global context and covering a diverse range of countries
Book Synopsis Marine Enzymes for Biocatalysis by : Antonio Trincone
Download or read book Marine Enzymes for Biocatalysis written by Antonio Trincone and published by Elsevier. This book was released on 2013-09-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Marine bioprospecting is a highly topical subject - in both applied and basic research - but, as yet, the marine ecosystem is a relatively unexplored source of natural bioactive substances with potential therapeutic activity. This book addresses the use of marine enzymes in biocatalysis through a series of chapters from leading scientists within academic and industrial fields. Biocatalytic processes can take advantage of the habitat-related properties of marine enzymes, such as salt tolerance, hyperthermostability, barophilicity, cold adaptivity, and so on, whilst also taking into consideration substrate specificity and affinity. These evolved properties are linked to the metabolic functions of the enzymes and to the ecological aspects of the natural source. New properties can also be discovered at the molecular level of catalysis, particularly concerning the stereochemical characteristics of products.Marine enzymes for biocatalysis initially examines the nature and level of interest in marine biological diversity, and outlines the fundamentals of biocatalysis. It goes on to detail sources of marine enzymes, and to analyse examples from both chemical and stereochemical viewpoints of catalysis, including microbial enzymes and animal or plant sources. The book goes on to explore the future potential of marine bioprospecting in biocatalysis. - Compiles studies from leading scientists in a direct and accessible format. Includes practical descriptions of results, adding further details not often covered in formal articles - Takes a molecular view which fully explains the enzymatic aspects of reactions, particularly regarding biocatalytic characteristics and descriptions of bioprocesses - Selects examples of chemical and stereochemical aspects of enzymatic action with respect to known terrestrial counterparts
Book Synopsis Nanoparticulate Drug Delivery by : Vandana Patravale
Download or read book Nanoparticulate Drug Delivery written by Vandana Patravale and published by Elsevier. This book was released on 2012-10-31 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use and characterization of nanoparticulate systems as drug carriers, including the assessment of their morphology, sterility and potential toxicity. In the latter part of the book, chapters cover nanotoxicology, regulatory aspect and clinical trials, ending with an overview of several case studies and a look towards future developments. - Discusses the issues surrounding nanoparticulate products, based on personal experience of their formulation - Provides an overview of new application areas, including RNA interference - Outlines the pros and cons of nanoparticulate products, and discusses how these may influence their route into the commercial sector
Book Synopsis Lean Biomanufacturing by : Nigel J Smart
Download or read book Lean Biomanufacturing written by Nigel J Smart and published by Elsevier. This book was released on 2013-10-31 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
Book Synopsis Transporters in Drug Discovery and Development by : Yurong Lai
Download or read book Transporters in Drug Discovery and Development written by Yurong Lai and published by Woodhead Publishing. This book was released on 2014-08-22 with total page 759 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery and developments. - A comprehensive overview of drug transporter families and their clinical relevance in drug discovery and development - Balanced coverage of molecular biology aspects and functional outcomes - State of art knowledge related to transporter-mediated DDI and the clinical relevance in pharmacokinetics, dynamics, and toxicity
Book Synopsis Stem Cell Bioprocessing by : Tiago G. Fernandes
Download or read book Stem Cell Bioprocessing written by Tiago G. Fernandes and published by Elsevier. This book was released on 2013-11-15 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion, and stem cell separation techniques such as isolation and purification are discussed. Basic definitions are provided concerning the different types of stem cells, from adult stem cells to the more recent induced pluripotent stem cells. The main characteristics of these different stem cell types are described, alongside the molecular mechanisms underlying their self-renewal and differentiation. The book also focuses on methodologies currently used for in vitro stem cell culture under static conditions, including the challenge of xeno-free culture conditions, as well as culture parameters that influence stem cell culture. Approaches for both stem cell culture and separation in micro-scale conditions are presented, including the use of cellular microarrays for high-throughput screening of the effect of both soluble and extracellular matrix molecules. A further section is dedicated to application of stem cells for regenerative medicine. - Maintains a unique focus on both the basic stem cell biology concepts, and their translation to large-scale bioprocessing approaches - Envisages the use of stem cells in regenerative medicine and drug screening applications - Discusses the application of microscale techniques as a tool to perform basic stem cell biology studies
Book Synopsis Bacterial Cellular Metabolic Systems by : K. Shimizu
Download or read book Bacterial Cellular Metabolic Systems written by K. Shimizu and published by Elsevier. This book was released on 2013-03-26 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The metabolic regulation of a cell system is of critical importance in systems biology, and a robust model of these mechanisms is essential in predicting the effects on the metabolism of both the culture environment and the knockout of specific genes. Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches. The book begins with an introduction to metabolic mechanisms and to the metabolic regulation of a cell, before moving on to discussing the action of global regulators in response to a specific culture environment. The second half of the book examines conventional flux balance analysis and its applications, 13C-metabolic flux analysis, and the effect of a specific gene knockout on the metabolism. - Comprehensive account of metabolic regulation via global regulators in response to changes in the culture environment - Basic formulation of 13C-metabolic flux analysis based on 13C-labelling experiments - Systems biology approach for the modelling and computer simulation of the main metabolic pathways of a cell system
Book Synopsis NMR Metabolomics in Cancer Research by : Miroslava Čuperlović-Culf
Download or read book NMR Metabolomics in Cancer Research written by Miroslava Čuperlović-Culf and published by Elsevier. This book was released on 2012-12-17 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics in cancer research, the book begins with an examination of the cancer metabolic phenotype and experimental methodology, before moving on to cover data pre-processing and data analysis. Chapters in the latter part of the book look at dynamic metabolic profiling, biomarker discovery, and the application of NMR metabolomics for different types of cancer, before a concluding chapter discusses future perspectives in the field. - Focused description of NMR spectroscopy needed by cancer biologists who are starting to use metabolomics - Current overview of knowledge related to the cancer metabolic phenotype from the perspective of metabolomics applications - Information about the best practices in NMR metabolomics experimentation and data preprocessing as applied to different sample types
Book Synopsis From Plant Genomics to Plant Biotechnology by : Palmiro Poltronieri
Download or read book From Plant Genomics to Plant Biotechnology written by Palmiro Poltronieri and published by Elsevier. This book was released on 2013-08-31 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory, the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims. In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications.This book covers these issues, showing how such technologies are influencing the plant field in sectors such as the selection of plant varieties and plant breeding, selection of optimum agronomic traits, stress-resistant varieties, improvement of plant fitness, improving crop yield, and non-food applications in the knowledge based bio-economy. - Discusses a broad range of applications: the examples originate from a variety of sectors (including in field studies, breeding, RNA regulation, pharmaceuticals and biotech) and a variety of scientific areas (such as bioinformatics, -omics sciences, epigenetics, and the agro-industry) - Provides a unique perspective on work normally performed 'behind closed doors'. As such, it presents an opportunity for those within the field to learn from each other, and for those on the 'outside' to see how different groups have approached key problems - Highlights the criteria used to compare and assess different approaches to solving problems. Shows the thinking process, practical limitations and any other considerations, aiding in the understanding of a deeper approach
Book Synopsis Allergens and Respiratory Pollutants by : Marc A. Williams
Download or read book Allergens and Respiratory Pollutants written by Marc A. Williams and published by Elsevier. This book was released on 2011-07-18 with total page 315 pages. Available in PDF, EPUB and Kindle. Book excerpt: Allergens and respiratory pollutants is a collection of 12 authoritative papers that draws upon the collective expertise of world leaders in the fields of innate immunity, immunotoxicology and pulmonary biology. The book critically explores the biological and immunological mechanisms that contribute to immune dysfunction on exposure to allergens and the susceptibility to infectious disease on exposure to ambient pollutants. The clinical relevance of exposure to ambient airborne xenobiotics is critically discussed and collectively, this book provides an educational forum that links the health effects of environmental exposures, immune dysfunction and inflammatory airways disease. - Discusses recent advances in our understanding of cell-mediated innate immune mechanisms that occur during allergic inflammation and provides important timely coverage of diseases of concern and how such diseases are influenced by a dysfunctional immune system - Provides useful information on linking environmental 'danger signals' that provoke immune dysfunction and exacerbation of existing disease - Draws upon the collective expertise of an international college of leaders in the field, but also provides chapters that provide essential reference material
