Your cart is empty
This "Second Edition" discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
Accelerated Path to Cures provides a transformative perspective on the power of combining advanced computational technologies, modeling, bioinformatics and machine learning approaches with nonclinical and clinical experimentation to accelerate drug development. This book discusses the application of advanced modeling technologies, from target identification and validation to nonclinical studies in animals to Phase 1-3 human clinical trials and post-approval monitoring, as alternative models of drug development. As a case of successful integration of computational modeling and drug development, we discuss the development of oral small molecule therapeutics for inflammatory bowel disease, from the application of docking studies to screening new chemical entities to the development of next-generation in silico human clinical trials from large-scale clinical data. Additionally, this book illustrates how modeling techniques, machine learning, and informatics can be utilized effectively at each stage of drug development to advance the progress towards predictive, preventive, personalized, precision medicine, and thus provide a successful framework for Path to Cures.
This series of books provides coverage of all of the major analytical techniques and their application in the most important areas of physical, life and materials science. Each text is presented in an open learning/distance learning style, in which the learning objectives are clearly identified. The reader's understanding of the material is constantly evaluated by the use of self-assessment and discussion questions. Series Editor: David J. Ando
It is now recognized that, in order to ensure the validity of a forensic science analysis, a number of criteria need to be met. These include the following:
In this book, the major classes of drugs of abuse are addressed, the analysis of which follows a systematic framework, including description, presumptive testing, thin layer chromatography, instrumental methods and data analysis. Throughout the text, regular questions and answers are used to further develop an understanding of the processes being employed.
This book will appeal to both undergraduate and postgraduate students of forensic science, as well as those practitioners who are new in post or receiving additional or refresher training. It should also be of benefit to those who are studying controlled substances as broadening courses in other scientific disciplines.
Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields. Biocatalysis in the Pharmaceutical and Biotechnology Industries examines the use of catalysts to produce fine chemicals and chiral intermediates in a variety of pharmaceutical, agrochemical, and other biotechnological applications.
Written by internationally recognized scientists in biocatalysis, the authors analyze the synthesis of chiral intermediates for over 60 brand-name pharmaceuticals for a wide range of drug therapies and treatments. From starting material to product, the chapters offer detailed mechanisms that show chiral intermediates and other by-products for each reaction-including hydrolytic, acylation, halogenation, esterification, dehalogenation, oxidation-reduction, oxygenation, hydroxylation, deamination, transamination, and C-C, C-N, C-O bonds formation. Cutting-edge topics include advanced methodologies for gene shuffling and directed evolution of biocatalysts; the custom engineering of enzymes; the use of microbial cells and isolated biocatalysts; the use of renewable starting materials; and generating novel molecules by combinatorial biocatalysis and high-throughput screening.
Focusing on industrial applications, the book also considers factors such as bulk processes, instrumentation, solvent selection, and techniques for catalyst immobilization, reusability, and yield optimization throughout. Biocatalysis in the Pharmaceutical and Biotechnology Industries showcases the practical advantages and methodologies for using biocatalysts todevelop and produce chiral pharmaceuticals and fine chemicals.
Offering step-by-step technical details, Liposome Technology, Third Edition, Three Volume Set provides comprehensive coverage of all aspects of liposome technology, including liposome preparation and analysis, entrapment of drugs and other materials into liposomes, and liposome interaction with the biological environment to be applied in the detection, therapy, or prevention of disease. The text offers critical discussions of the methodologies of each technology discussed so that readers can examine the benefits and limitations and compare it to other methods. This Third Edition features 55 chapters written by leading international experts. Because of the considerable progress in liposome related techniques and their application in therapy since the publication of the Second Edition in 1992, over half of the chapters are new to the edition, and the other chapters have been extensively updated. Liposome Technology, Third Edition, Three Volume Set is an ideal resource for pharmaceutical scientists, researchers, regulatory personnel, FDA personnel, and medicinal chemists working in this discipline.
Liposome Technology, Volume I: Liposome Preparation and Related Techniques, Third Edition, is a thoroughly updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume I illustrates numerous methods for liposome preparation and auxiliary techniques necessary for the stabilization and characterization of liposomes. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.
Polymers are one of the most fascinating materials of the present era finding their applications in almost every aspects of life. Polymers are either directly available in nature or are chemically synthesized and used depending upon the targeted applications.Advances in polymer science and the introduction of new polymers have resulted in the significant development of polymers with unique properties. Different kinds of polymers have been and will be one of the key in several applications in many of the advanced pharmaceutical research being carried out over the globe. This 4-partset of books contains precisely referenced chapters, emphasizing different kinds of polymers with basic fundamentals and practicality for application in diverse pharmaceutical technologies. The volumes aim at explaining basics of polymers based materials from different resources and their chemistry along with practical applications which present a future direction in the pharmaceutical industry. Each volume offer deep insight into the subject being treated. Volume 1: Structure and Chemistry Volume 2: Processing and Applications Volume 3: Biodegradable Polymers Volume 4: Bioactive and Compatible Synthetic/Hybrid Polymers
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. * Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing * Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design * Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions * Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Fluorine chemistry is an expanding area of research that is attracting international interest, due to the impact of fluorine in drug discovery and in clinical and molecular imaging (e.g. PET, MRI). Many researchers and academics are entering this area of research, while scientists in industrial and clinical environments are also indirectly exposed to fluorine chemistry through the use of fluorinated compounds for imaging.This book provides an overview of the impact that fluorine has made in the life sciences. In the first section, the emphasis is on how fluorine substitution of amino acids, peptides, nucleobases and carbohydrates can provide invaluable information at a molecular level. The following chapters provide answers to the key questions posed on the importance of fluorine in drug discovery and clinical applications. For examples, the reader will discover how fluorine has found its place as a key element improving drug efficacy, with reference to some of the best-selling drugs on the market. Finally, a thorough review on the design, synthesis and use of 18F-radiotracers for positron emission tomography is provided, and this is complemented with a discussion on how 19F NMR has advanced molecular and clinical imaging.
This SpringerBrief provides an overview of ultrasonic emulsification and an update on recent advances in developing stable emulsions for the creation of novel drugs and functional foods, with a focus on bioactive delivery in these products. Emulsification is the process of combining two or more immiscible liquids to form a semi-stable mixture. These two liquids generally consist of an organic (oil) phase and an aqueous (water) phase that is stabilized by the addition of an emulsifier. Most common emulsions are of the oil-in-water (O/W) type, but can also be of water-in-oil (W/O) or even multiple emulsion types (i.e. double emulsions) in the form of water-in-oil-in-water (W/O/W) or oil-in-water-in-oil (O/W/O) phases. The formation of an emulsion requires input of energy to distribute the disperse phase in the continuous phase in small-sized droplets that are able to resist instability. There is great interest in the use of ultrasound to produce emulsions, as it is able to do so relatively efficiently and effectively compared to existing techniques such as rotor stator, high-pressure homogenization and microfluidization. The interaction of ultrasound with the hydrocolloids and biopolymers that are often used to stabilize emulsions can offer advantages such as improved stability or greater control of formed droplet size distributions.
In the past decade there has been a worldwide evolution in evidence-based medicine that focuses on real-world Comparative Effectiveness Research (CER) to compare the effects of one medical treatment versus another in real world settings. While most of this burgeoning literature has focused on research findings, data and methods, Howard Birnbaum and Paul Greenberg (both of Analysis Group) have edited a book that provides a practical guide to decision making using the results of analysis and interpretation of CER. Decision Making in a World of Comparative Effectiveness contains chapters by senior industry executives, key opinion leaders, accomplished researchers, and leading attorneys involved in resolving disputes in the life sciences industry. The book is aimed at 'users' and 'decision makers' involved in the life sciences industry rather than those doing the actual research. This book appeals to those who commission CER within the life sciences industry (pharmaceutical, biologic, and device manufacturers), government (both public and private payers), as well as decision makers of all levels, both in the US and globally.
Nanostructures for Novel Therapy: Synthesis, Characterization and Applications focuses on the fabrication and characterization of therapeutic nanostructures, in particular, synthesis, design, and in vitro and in vivo therapeutic evaluation. The chapters provide a cogent overview of recent therapeutic applications of nanostructured materials that includes applications of nanostructured materials for wound healing in plastic surgery and stem cell therapy. The book explores the promise for more effective therapy through the use of nanostructured materials, while also assessing the challenges their use might pose from both an economic and medicinal point of view. This innovative look at how nanostructured materials are used in therapeutics will be of great benefit to researchers, providing a greater understanding of the different ways nanomaterials could improve medical treatment, along with a discussion of the obstacles that need to be overcome in order to guarantee widespread availability.
In this ground-breaking practical reference, the family of aspartic
acid proteases is described from a drug developer's perspective.
The first part provides a general introduction to the family of
aspartic acid proteases, their physiological functions, molecular
structure and inhibition. Parts two to five present various case
studies of successful protease inhibitor drug design and
development, as well as current and potential uses of such
inhibitors in pharmaceutical medicine, covering the major
therapeutic targets HIV-1 protease, renin, beta-secretase,
gamma-secretase, plasmepsins and fungal proteases.
Ibuprofen has become one of the foremost pain-relieving medications world-wide with its proven safety and efficacy in a wide variety of painful and inflammatory conditions. It has also been widely investigated for application in a variety of painful and non-pain inflammatory states including cancer and neurodegenerative conditions, reflecting the unique and novel properties of the drug that would never have been foreseen from knowledge of the properties when it was initially discovered. * Edited by leading world expert with over 40 years record in research, teaching and as a scientific advisor in the field of anti-inflammatory/analgesic agents. Professor Kim Rainsford is also the founding Editor-in-Chief of the journal, Inflammopharmacology, as well as being an Associate Editor of The Journal of Pharmacy & Pharmacology. * Provides a thorough coverage of the medicinal chemistry and pharmaceutics of ibuprofen, and its pharmacokinetics in both humans and animals. * Includes molecular, pharmacological and toxicological studies, and discusses the safety and efficacy of non-prescription ibuprofen, including its side effects. Ibuprofen: Discovery, Development & Therapeutics provides a definitive reference on all the main aspects of the chemical and pharmaceutical properties, mechanisms of action and therapeutic uses of ibuprofen including its role in the prevention and treatment of rheumatic conditions, cancer and neurodegenerative conditions such as Alzheimer s and Parkinson s diseases. The book has its origins in a volume first published in 1999, since when there have been considerable advances in research and clinical studies on ibuprofen in the treatment of many inflammatory and even non-inflammatory states. This book will prove invaluable to scientists, clinicians, pharmacists and all those who need to know about the actions and uses of anti-inflammatory and analgesic drugs.
As our understanding of the science and functions of color in food has increased, the preferred colorants, forms of use, and legislation regulating their uses have also changed. Natural Colorants for Food and Nutraceutical Uses reflects the current tendency to use natural pigments. It details their science, technology, and applications as well as their nutraceutical properties.
Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference.
Demonstrates how substitution of a variety of ligands can render
albumin a versatile targeting tool for selective drug accumulation
in various cell populations of the liver
Furthering efforts to simulate the potency and specificity
exhibited by peptides and proteins in healthy cells, this
remarkable reference supplies pharmaceutical scientists with a
wealth of techniques for tapping the enormous therapeutic potential
of these molecules-providing a solid basis of knowledge for new
Ibuprofen is widely used throughout the world for a variety of conditions. This reference work provides a comprehensive and critical review of the basic science and clinical aspects of the drug. The book begins with the history and development of the drug and its current patterns of use world- wide before moving on to examine its basic pharmaceutical attributes and medicinal chemistry. The properties of various formulations are described (oral prescription and OTC, topical and others) are described. The pharmacokinetics of ibuprofen in animals and humans is discussed - highlighting the factors affecting absorption, distribution, metabolism and elimination. The clinical pharmacology and toxicology and the drug's mechanisms of action in different disease states and conditions are covered. The therapeutic uses in various acute and inflammatory conditions is detailed. Also considered are the safety versus efficacy issues and the pharmacoepidemiological data.
Most clinical laboratory tests utilize interstitial and extravascular such as blood, urine, cerebral spinal fluid (CSF), and saliva. For example, CSF is monitored in the context of cancer for both diagnostic and therapeutic reasons. And yet, our understanding of the makeup of interstitial fluids, their relationships to disease, as well as their commercial importance in therapeutics and diagnostics remains rudimentary. Although sometimes perceived as static, interstitial and extravascular fluids are surprisingly dynamic. More than half of serum albumin is in the extravascular space. These fluids move rapidly between the intravascular and extravascular spaces - one entire plasma volume is exchanged very nine hours. In the first half of the book, the authors cover fundamental concepts of interstitial fluids, including their composition and function. They then further review the mechanisms by which interstitial fluids are regulated, characterizing the importance of hyaluronan - a major constituent of interstitial spaces and an a component of synovial fluid; and, outlining the regulation of proteolysis in the interstitial space. In the second half of the book, the authors focus on the coagulation system. This system has been studied extensively in the context of vascular spaces. But many of its components exist in the interstitial spaces. Chapters are devoted to the fibrinolytic system, kallikrein, matrix metalloproteinases, coagulation factors, and protease inhibitors - all are interstitial. By covering a unique array of topics with broad application to biomedical scientists, this book expands our understanding of the importance of interstitial spaces and the fluids that move through and reside in this extravascular environment.
Intended for medicinal chemists, pharmaceutical scientists, pharmacologists, immunologists, biochemists and microbiologists, this book provides both a broad overview of the current methodologies being applied to drug design and in-depth analyses of progress in specific fields. It offers state-of-the-art approaches to pharmaceutical development, including biological technologies currently used by some of the world's foremost laboratories. Features include: discussion of new techniques; previously unpublished data; and extensive reference lists.
The first contribution presents coumarins, the largest group of 1-benzopyran derivatives found in plants. Coumarin chemistry remains one of the major interest areas of phytochemists, especially because of their structural diversity and medicinal properties, along with the wide-ranging bioactivities of these compounds, inclusive of analgesic, anticoagulant anti-HIV, anti-inflammatory, antimicrobial, antineoplastic, antioxidant, and immunomodulatory effects. The second contribution presents a comprehensive survey of the many aspects of PAD biochemistry and physiology. The third contribution gives a comprehensive overview of secondary metabolites from higher fungi, with more than 700 references highlighting the isolation, structure elucidation, biological activities, chemical synthesis, and biosynthesis of pigments, nitrogen-containing compounds, and terpenoids from mushrooms.
Over the past two decades the benefits of label-free biosensor analysis have begun to make an impact in the market, and systems are beginning to be used as mainstream research tools in many drug discovery laboratories.
"Label-Free Technologies For Drug Discovery" summarises the latest and emerging developments in label-free detection systems, their underlying technology principles and end-user case studies that reveal the power and limitations of label-free in all areas of drug discovery.
Label-free technologies discussed include SPR, NMR, high-throughput mass spectrometry, resonant waveguide plate-based screening, transmitted-light imaging, isothermal titration calorimetry, optical and impedance cell-based assays and other biophysical methods. The technologies are discussed in relation to their use as screening technologies, high-content technologies, hit finding and hit validation strategies, mode of action and ADME/T, access to difficult target classes, cell-based receptor/ligand interactions particularly orphan receptors, and antibody and small molecule affinity and kinetic analysis.
"Label-Free Technologies For Drug Discovery" is an essential guide to this emerging class of tools for researchers in drug discovery and development, particularly high-throughput screening and compound profiling teams, medicinal chemists, structural biologists, assay developers, ADME/T specialists, and others interested in biomolecular interaction analysis.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
You may like...
Pharmaceutical Crystallography - A Guide…
Andrew Bond Hardcover R1,045 Discovery Miles 10 450
Drug Metabolism Prediction
Johannes Kirchmair Hardcover
Phosphodiesterases and Their Inhibitors
Spiros Liras, Andrew S. Bell Hardcover
Scaffold Hopping in Medicinal Chemistry
Nathan Brown Hardcover
Trypanosomatid Diseases - Molecular…
Timo Jager, Oliver Koch, … Hardcover
Biopharmaceutical Production Technology…
Ganapathy Subramanian Hardcover
NMR in Pharmaceutical Science
Jeremy R. Everett, John C. Lindon, … Hardcover
Medicinal Chemistry Approaches to…
Karen Lackey, Bruce Roth Hardcover
Pharmaceutical Salts - Properties…
P.Heinrich Stahl, Camille Georges Wermuth Hardcover
Management of Chemical and Biological…
Mark Wigglesworth, Terry Wood Hardcover