Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.
Download or read book Oratory in the Kings Sagas written by James E. Knirk and published by . This book was released on 1981 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Surface and Colloid Chemistry written by K. S. Birdi and published by CRC Press. This book was released on 2015-06-25 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of the Handbook of Surface and Colloid Chemistry informs you of significant recent developments in the field. It highlights new applications and provides revised insight on surface and colloid chemistry's growing role in industrial innovations. The contributors to each chapter are internationally recognized experts. Several chapter
Download or read book Silicate Melts written by Sharon Webb and published by Springer. This book was released on 1997-07-17 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the experimental determination of the physical properties of silicate melts and magmas close to glass transition. Abundant new data are presented. The same type of measurement is performed on a range of melts to test the effect of composition on physical properties; and a range of different techniques are used to determine the same physical properties to illustrate the relationships between the relaxation of the melt structure and the relaxation of its physical properties. This book is of interest to experimental researchers in the discussion of data obtained from both a materials science and a geoscientific point of view.
Download or read book The Secret Language of Influence written by Dan Seidman and published by AMACOM. This book was released on 2012-04-11 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning the use of storytelling, humor, emotion-evoking language, and questions that advance the sale, this entertaining and practical book demonstrates the power of words to break down resistance and incline buyers toward purchase. A few simple words--the right words--can transform an awkward sales call into a comfortable conversation and a resistant prospect into a happy customer, which is why author Dan Seidman teaches you to think of influence as something occurring at a level just below the buyer’s awareness. The Secret Language of Influence does this by explaining not only how to identify the right words--and which to avoid--but how to use strategic key words and phrases with different potential buyers. You’ll learn the best ways to approach buyers who are: motivated by benefits vs. problems (i.e., wanting to hear about the money they’ll save rather than the pain they’ll avoid); proactive vs. reactive; big picture vs. detail oriented; systems thinkers vs. creative minds; and those who are influenced by external feedback (testimonials, evidence) vs. internal factors (feelings, personal experiences, beliefs). Today’s buyer is savvy and all too familiar with traditional selling techniques, but great selling is invisible. By identifying different ways buyers are motivated, salespeople can quickly customize their conversations and lead prospects to a yes.
Download or read book The Warm Valley People written by Harald O. Skar and published by . This book was released on 1988 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sol Gel Technologies for Glass Producers and Users written by Michel Andre Aegerter and published by Springer Science & Business Media. This book was released on 2013-03-19 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sol-Gel Techniques for Glass Producers and Users provides technological information, descriptions and characterizations of prototypes, or products already on the market, and illustrates advantages and disadvantages of the sol-gel process in comparison to other methods. The first chapter entitled "Wet Chemical Technology" gives a summary of the basic principles of the sol-gel chemistry. The most promising applications are related to coatings. Chapter 2 describes the various "Wet Chemical Coating Technologies" from glass cleaning to many deposition and post-coating treatment techniques. These include patterning of coatings through direct or indirect techniques which have became very important and for which the sol-gel processing is particularly well adapted. Chapter 3 entitled "Bulk Glass Technologies" reports on the preparation of special glasses for different applications. Chapter 4 entitled "Coatings and Materials Properties" describes the properties of the different coatings and the sol-gel materials, fibers and powders. The chapter also includes a section dedicated to the characterization techniques especially applied to sol-gel coatings and products.
Download or read book Inorganic Syntheses Volume 32 written by and published by John Wiley & Sons. This book was released on 2009-09-22 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Inorganic Synthesis Series provides all users of inorganic substances with detailed and foolproof procedures for the preparation of important and timely compounds. This new volume includes information on water-solubilizing ligands for organometallics, labile ligand complexes, and the syntheses of cluster compounds and hydrides.
Download or read book NMR Based Metabolomics written by G. A. Nagana Gowda and published by Humana. This book was released on 2020-08-29 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides broad coverage of nuclear magnetic resonance (NMR) spectroscopy-based methods and applications for the analysis of metabolites in a wide range of biological samples, from biofluids, cells, animal models, human, to plants and foods. The applications range from mechanistic understanding, biomarker discovery, environmental studies, and drug discovery to nutrition, while NMR methods include global, targeted, and isotope tracer-based techniques. 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, NMR-Based Metabolomics: Methods and Protocols serves as a wealth of information for beginners as well as advanced practitioners and also as stepping stones for further advances in the field of metabolomics.
Download or read book Cosmetic Microbiology written by Philip A. Geis and published by CRC Press. This book was released on 2020-12-06 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated edition provides research scientists, microbiologists, process engineers, and plant managers with an authoritative resource on basic microbiology, manufacturing hygiene, and product preservation. It offers a contemporary global perspective on the dynamics affecting the industry, including concerns about preservatives, natural ingredients, small manufacturing, resistant microbes, and susceptible populations. Professional researchers in the cosmetic as well as the pharmaceutical industry will find this an indispensable textbook for in-house training that improves the delivery of information essential to the development and manufacturing of safe high-quality products
Download or read book Fluid Cracking Catalysts written by Mario L. Occelli and published by CRC Press. This book was released on 1998-01-05 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews recent accomplishments in the field of fluid cracking catalysts (FCC). Discusses the development of more specialized and effective catalysts and processes as well as the modification of current technology to meet future challenges in fuel refining. Written by nearly 50 internationally recognized experts from academia and industry.
Download or read book Advances in MALDI and Laser Induced Soft Ionization Mass Spectrometry written by Rainer Cramer and published by Springer. This book was released on 2015-11-09 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the state-of-the-art of modern MALDI (matrix-assisted laser desorption/ionization) and its applications. New applications and improvements in the MALDI field such as biotyping, clinical diagnosis, forensic imaging, and ESI-like ion production are covered in detail. Additional topics include MS imaging, biotyping/speciation and large-scale, high-speed MS sample profiling, new methods based on MALDI or MALDI-like sample preparations, and the advantages of ESI to MALDI MS analysis. This is an ideal book for graduate students and researchers in the field of bioanalytical sciences. This book also: • Showcases new techniques and applications in MALDI MS • Demonstrates how MALDI is preferable to ESI (electrospray ionization) • Illustrates the pros and cons associated with biomarker discovery studies in clinical proteomics and the various application areas, such as cancer proteomics
Download or read book Bioinorganic Chemistry of Copper written by K.D. Karlin and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioinorganic Chemistry of Copper focuses on the vital role of copper ions in biology, especially as an essential metalloenzyme cofactor. The book is highly interdisciplinary in its approach--the outstanding list of contributors includes coordination chemists, biochemists, biophysicists, and molecular biologists. Chapters are grouped into major areas of research interest in inorganic copper chemistry, spectroscopy, oxygen chemistry, biochemistry, and molecular biology. The book also discusses basic research of great potential importance to pharmaceutical scientists. This book is based on the first Johns Hopkins University Copper Symposium, held in August 1992. Researchers in chemistry, biochemistry, molecular biology, and medicinal chemistry will find it to be an essential reference on its subject.
Download or read book Global Carbon Dioxide Recycling written by Koji Hashimoto and published by Springer. This book was released on 2019-05-24 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: This brief describes the current critical situation of global warming and shows its solution by renewable energy use. The author has long studied the development of new materials with chemical functions and is renowned as the first advocate of power-to-gas. He established the technology to convert renewable energy to synthesized natural gas, methane by electrolytic hydrogen generation using surplus electricity from renewable energy, and subsequent methanation of carbon dioxide by reaction with hydrogen.In the first part of this brief, data on global warming and energy consumption are shown and analyzed from the author’s keen point of view. The second part introduces the author’s research results on key materials for global carbon dioxide recycling and constructed pilot plants based on them. Finally, an evidence-based solution to maintain sustainable development by using only renewable energy is described as a future prospect.This book is useful not only for researchers and students studying chemical engineering, materials, or energy, but also for general citizens who are interested in the global environment.
Download or read book Summary Report on Emissions from the Glass Manufacturing Industry written by E. D. Spinosa and published by . This book was released on 1979 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Natural Killer Cell Protocols written by Kerry S. Campbell and published by Springer Science & Business Media. This book was released on 2008-02-03 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Natural Killer Cell Protocols: Cellular and Molecular Methods, Kerry S. Campbell and Marco Colonna have assembled a comprehensive collection of readily reproducible methods designed to study natural killer (NK) cells from the broadest variety of viewpoints. These include not only classic techniques, but also new approaches to standard methods, newly evolved techniques that have become valuable for specific applications, and unique models for manipulating and studying NK cells. Among the advanced methods covered are those for in vitro transendothelial migration, in vivo detection of cells migrating into tumors, immunofluorescence staining of intracellular cytokines, and in vitro NK cell development. Valuable techniques for specific applications include vaccinia virus protein expression, soluble KIR-Fc fusions for HLA class I binding assays, calcium mobilization in cell conjugates, and identification of heterodimeric receptor complexes using cDNA library expression cloning. No less important are accounts of such classic methods as hybrid resistance, ADCC, viral defense, target cell cytotoxicity assays, cloning and culturing, tumor immunotherapy, and generation of HLA class I transfected target cells. Natural Killer Cell Protocols: Cellular and Molecular Methods offers immunologists, cancer researchers, virologists, and cell biologists today's most comprehensive collection of both established and cutting-edge techniques, methods that will contribute significantly to advancing our understanding of this fascinating and critically important class of cells.
Download or read book Optical Fibers Research Advances written by Jürgen C. Schlesinger and published by Nova Publishers. This book was released on 2007 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: An optical fibre is a glass or plastic fibre designed to guide light along its length by confining as much light as possible in a propagating form. In fibre with large core diameter, the confinement is based on total internal reflection. In smaller diameter core fibres, (widely used for most communication links longer than 200 meters) the confinement relies on establishing a waveguide. Fibre optics is the overlap of applied science and engineering concerned with such optical fibres. Optical fibres are widely used in fibre-optic communication, which permits transmission over longer distances and at higher data rates than other forms of wired and wireless communications. They are also used to form sensors, and in a variety of other applications. The term optical fibre covers a range of different designs including graded-index optical fibres, step-index optical fibres, birefringent polarisation-maintaining fibres and more recently photonic crystal fibres, with the design and the wavelength of the light propagating in the fibre dictating whether or not it will be multi-mode optical fibre or single-mode optical fibre. Because of the mechanical properties of the more common glass optical fibres, special methods of splicing fibres and of connecting them to other equipment are needed. Manufacture of optical fibres is based on partially melting a chemically doped pre-form and pulling the flowing material on a draw tower. Fibres are built into different kinds of cables depending on how they will be used. This new book presents the latest research in the field.