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This publication details the isolation of proteins from biological materials, techniques for solid-liquid separation, concentration, crystallization, chromatography, scale-up, process monitoring, product formulation, and regulatory and commercial considerations in protein production. The authors discuss the release of protein from a biological host, selectivity in affinity chromatography, precipitation of proteins (both non-specific and specific), extraction for rapid protein isolation, adsorption as an initial step for the capture of proteins, scale-up and commercial production of recombinant proteins, and process monitoring in downstream processing.
Filling a gap in the market, this two-volume set is the first to present important pharmaceuticals as well as agrochemical pesticides in one handy work.Each of the around 40 chapters covers in a concise manner one class of heterocycles, clearly structured as follows: * Structural formulas of most important examples (market products)* Short background of history or discovery* Typical syntheses of important examples* Mode of action* Characteristic biological activity* Structure-activity relationship* Additional chemistry information (e.g. further transformations, alternative syntheses, metabolic pathways, etc.)* References.A valuable one-stop reference source for researchers in academia and industry as well as for graduate students with career aspirations in the field of pharmaceutical and agrochemical chemistry.
Take advantage of the introductory price available until 31st January 2013 - 205.00 / $330.00 / 229.00, thereafter 245.00 / $405.00 / 299.00
Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
The Handbook of Pharmaceutical Controlled Release Technology reviews the design, fabrication, methodology, administration, and classifications of various drug delivery systems, including matrices, and membrane controlled reservoir, bioerodible, and pendant chain systems. Contains cutting-edge research on the controlled delivery of biomolecules! Discussing the advantages and limitations of controlled release systems, the Handbook of Pharmaceutical Controlled Release Technology -covers oral, transdermal, parenteral, and implantable delivery of drugs -discusses modification methods to achieve desired release kinetics -highlights constraints of system design for practical clinical application -analyzes diffusion equations and mathematical modeling -considers environmental acceptance and tissue compatibility of biopolymeric systems for biologically active agents -evaluates polymers as drug delivery carriers -describes peptide, protein, micro-, and nanoparticulate release systems -examines the cost, comfort, disease control, side effects, and patient compliance of numerous delivery systems and devices -and more!
"Provides a wide range of information on the composition, utilization, and evaluation of colorants and pigments in food, pharmaceuticals, and cosmetic products. Tabulates key data for food, drug, and cosmetic colorants by Color Index Numbers. Thoroughly describes the relationships between coloring reactions."
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.
The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.
This practical guide offers concise coverage of the scientific and pharmaceutical aspects of protein delivery from controlled release microparticulate systems-emphasizing protein stability during encapsulation and release.
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. - Guides researchers as to what drug safety experiments are both practical and useful - Covers a variety of key topics - safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and -omics tools - Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods - Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
This work describes all known assays used to discover new glycopeptide antibiotics. It discusses practical techniques for screening, isolating and analyzing glycopeptide antibiotics, correlating structure-activity relationships with the mode of action. Every relevant chemical aspect of the carbohydrate components of glycopeptide antibodies is examined.
This comprehensive, first-of-its kind title is an indispensable resource for pharmacists looking to learn or improve crucial patient assessment skills relevant to all pharmacy practice settings. Pharmacists' role as health care practitioners is evolving as they are taking a more active part in primary patient care -- helping patients manage their medications and diseases, providing patient education, and, in some jurisdictions, prescribing and adapting medications. To perform their day-to-day duties, pharmacists are best-served using a framework called the patient care process. This framework involves three steps: patient assessment; care plan development and implementation; and monitoring and follow up. Organized in four parts, this practical book begins with introductory chapters regarding the basics of patient assessment and the patient care process. Part II includes a detailed assessment of common symptoms encountered by pharmacists. Part III discusses assessment of patients with various chronic illnesses. Part IV addresses select specialized topics and assessment considerations. An invaluable contribution to the literature, Patient Assessment in Clinical Pharmacy: A Comprehensive Guide will be of great benefit to pharmacists, regardless of their practice setting, and to pharmacy students as well.
This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
The application of knowledge of drug disposition, and skills in pharmacokinetics, are crucial to the development of new drugs and to a better understanding of how to achieve maximum benefit from existing ones. The book takes the reader from basic concepts to a point where those who wish to will be able to perform pharmacokinetic calculations and be ready to read more advanced texts and research papers. The book will be of benefit to students of medicine, pharmacy, pharmacology, biomedical sciences and veterinary science, including those who have elected to study the topic in more detail, such as via electives and special study modules. It will be of benefit to those involved in drug discovery and development, pharmaceutical and medicinal chemists, as well as budding toxicologists and forensic scientists who require the appropriate knowledge to interpret their findings and as an introductory text for clinical pharmacologists. Early chapters describe the basic principles of the topic while the later ones illustrate the application of those principles to modern approaches to drug development and clinical use. Full colour illustrations facilitate the learning experience and supporting material for course leaders and students can be found on the Companion Web Site
The identification of drug targets in a given disease has been central to pharmaceutical research from the latter half of the 20th century right up to the modern genomics era. Human Drug Targets provides an essential guide to one of the most important aspects of drug discovery the identification of suitable protein and RNA targets prior to the creation of drug development candidates. The first part of the book consists of introductory chapters that provide the background to drug target discovery and highlight the way in which these targets have been organised into online databases. It also includes a user s guide to the list of entries that forms the bulk of the book. Since this is not designed to be a compendium of drugs, the emphasis will be on the known (or speculated) biological role of the targets and not on the issues associated with pharmaceutical development. The objective is to provide just enough information to be informative and prompt further searches, while keeping the amount of text for each of the many entries to a minimum. Human Drug Targets will prove invaluable to those drug discovery professionals, in both industry and academia, who need to make some sense of the bewildering array of online information sources on current and potential human drug targets. As well as creating order out of a complex target landscape, the book will act as an ideas generator for potentially novel targets that might form the basis of future discovery projects.
This book covers the most up-to-date photoaffinity labeling method to tackle the key loop module involved in the binding process of a bioactive small molecule to its host protein. The book introduces rational points for preparing powerful photoaffinity probes, keys for the efficient analysis of labeled products, and recent successful applications for protein probing. Regarding drug design, the unique topics of the book are the special consideration of the crosslinking potential of recent probes and their application of important receptor proteins . This book presents emerging technologies of photoaffinity labeling to readers who are working in the fields of proteomics, molecular recognition, and drug discovery and development.
This book aims to provide a guide to researchers on how to work with Transient Receptor Potential (TRP) channels, describing current methodologies and protocols, and highlighting the challenges ahead that will require the development of new technologies. Articles cover a wide range of techniques, from structure to function, concluding with how to best to evaluate some of the in vivo function of TRP channels, particularly in regard to their involvement in hyperalgesia and allodynia. Also, the collection describes important and inspiring available tools that are currently being used to investigate the activity of these channels in vitro and in vivo in terms of their underlying protein structure, segueing into dealing with the generation of pharmacological tools to explore their in vivo activity and their involvement in cellular signaling pathways, which may be developed into drugs to treat diseases caused by channel dysfunction or hyperactivity. Written for the highly successful Methods in Molecular Biology series, chapters include the necessary detail and implementation advice to ensure successful results in the lab. Authoritative and practical, TRP Channels: Methods and Protocols is a useful set of methodologies for scientists seeking to better understand this vital family of channels.
Backed by leading authorities, this is a professional guide to successful compound screening in pharmaceutical research and chemical biology, including the chemoinformatic tools needed for correct data evaluation. Chapter authors from leading pharmaceutical companies as well as from Harvard University discuss such factors as chemical genetics, binding, cell-based and biochemical assays, the efficient use of compound libraries and data mining using cell-based assay results.
For both academics and professionals in the pharma and biotech industries working on small molecule screening.
This book highlights the recent advances of thermodynamics and biophysics in drug delivery nanosystems and in biomedical nanodevices. The up-to-date book provides an in-depth knowledge of bio-inspired nanotechnological systems for pharmaceutical applications. Biophysics and thermodynamics, supported by mathematics, are the locomotive by which the drug transportation and the targeting processes will be achieved under the light of the modern pharmacotherapy. They are considered as scientific tools that promote the understanding of physicochemical and thermotropic functionality and behavior of artificial cell membranes and structures like nanoparticulate systems. Therefore, this book focusses on new aspects of biophysics and thermodynamics as important elements for evaluating biomedical nanosystems, and it correlates their physicochemical, biophysical and thermodynamical behaviour with those of a living organism. In 2018, Prof. Demetzos was honored with an award by the Order of Sciences of the Academy of Athens for his scientific contribution in Pharmaceutical Nanotechnology.
The incorporation of functional ingredients in a given food system and the processing and handling of such foods are associated with nutritional challenges for their healthy delivery. The extreme sensitivity of some components cause significant loss of product quality, stability, nutritional value and bioavailability, and the overall acceptability of the food product. Consequently, encapsulation has been successfully used to improve stability and bioavailability of functional ingredients. Encapsulation is one example of technology that has the potential to meet the challenge of successfully incorporating and delivering functional ingredients into a range of food types. The book will cover topics about 1) Characterization of novel polymers and their use in encapsulation processes. 2) Stability of nutraceutical compounds encapsulated with novel polymers. 3) Application of encapsulated compounds with novel polymers in functional food systems. This book provides a detailed overview of technologies for preparing and characterisation of encapsulates for food active ingredients using modified polymers. The use of modified polymers as coating materials it is a field that still needs study. The book is aimed to inform students and researchers in the areas of food science and food technology, and professionals in the food industry.
Nuclear receptors are the site of action for some of the most
widely used medications, namely oral contraceptives and related
drugs derived from steroid hormones. Recent research has uncovered
their pivotal role in a range of human diseases, including diabetes
and metabolic syndrome, triggering a new wave of drug discovery
efforts focused on this class of molecular targets.
Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
This comprehensive text presents a rigorous framework from within which regulators can respond strategically to the claim by the pharmaceutical industry that lower drug prices today lead to a loss for the population's future health due to less innovation. It starts with a critical review of the empirical evidence of the return to consumers on their ongoing investment into high drug prices in order to increase future innovation. The implicit, critical and unrealistic assumption inherent in these studies is identified, namely that the health budget can be expanded to purchase drugs at higher prices without an opportunity cost, for example, the foregone benefits of alternative investments in health care infrastructure. Price effectiveness analysis (PEA), is introduced. PEA informs the question of how the innovative surplus from the new drug should be allocated between the manufacturer and the consumer so as to optimise society's welfare. The method allows the decisions by the regulator and the firm to be analysed jointly by specifying the firm's production and revenue functions in terms of the clinical innovation of a new drug; the incremental effect used in the summary metric of cost effectiveness analysis. An economic value of innovation that takes into account opportunity cost under conditions of economic efficiency in the health system is proposed: the health shadow price. The limitations of the non-strategic methods that currently inform the highly contested new drug subsidy game are presented and the relative strengths of PEA are demonstrated. Health technology assessment quantifies both the clinical innovation of a new drug and its financial impact on the health system. Cost effectiveness analysis tests the relationship between the incremental cost and incremental effect of a new drug for target patients, at a given price. PEA tests the relationship between the price of a new drug and the health of the whole population, now and into the future. It achieves this by taking into account current inefficiency in both resource allocation and the displacement process, and the relationship between price and future innovation.
The chemistry of heterocycles is an important branch of organic
chemistry. This is due to the fact that a large number of natural
products, e. g.
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