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This second edition book explores breakthrough technologies in the field of drug target identification and validation. The volume emphasizes particularly revolutionary technologies, such as CRISPR-related screening, "big data," and in silico approaches, as well as in vivo applications of CRISPR and best uses of animal models in drug development. 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. Fully updated and authoritative, Target Identification and Validation in Drug Discovery: Methods and Protocols, Second Edition is an ideal guide for molecular and cellular biologists, pharmacologists, pathologists, bioinformaticians, clinical researchers, or investigators, as well as experts in other fields that need a quick overview of these state-of-the-art technologies.
This book illustrates the current state-of-the-art in histamine research, with a focus on the appropriate methodologies to investigate the pharmacological properties and the therapeutic exploitation of HRs and their ligands. In addition, the range of techniques described provides an introduction to complementary cross-methodological disciplines beyond these fields. This multi-disciplinary approach is required to define the `decision gates' that determine the development of more effective and safer therapeutic options for many forms of highly prevalent and debilitating diseases, such as asthma, dementias, dermatitis, and arthritis. Written for the Methods in Pharmacology and Toxicology series, chapters concentrate on practical, hands-on protocols from experts in the techniques. Authoritative and thorough, Histamine Receptors as Drug Targets seeks to aid pharmacologists, biochemists, drug discovery researchers, molecular biologists, chemists, toxicologists, lab scientists, medical doctors, principle investigators, research scientists, lab directors and technicians, as well as graduate students around the world in pursuing the study of this vital scientific area.
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.
European pharmaceutical law can be a minefield, due to the peculiarities of the European single market, the complexity of contemporary issues, and the rapid pace of scientific advancement. This book offers a comprehensive and in-depth analysis of EU pharmaceutical law, including expert perspectives on the most cutting-edge and contentious legal issues faced by the industry today. It provides analytical and informed discussion of legislation and jurisprudence relevant to the entire lifecycle of pharmaceutical and biopharmaceutical products. This is supported by case studies and incisive commentary to give a full understanding of the controversial policy considerations which shape interpretation of the law in practice. The legislation does not always provide answers, and the book adopts a creative approach which addresses both what the law says and what the law does not say. Written by a team of experts in the field, Navigating European Pharmaceutical Law is an accessible guide for those new to the field, and an invaluable resource for experienced practitioners advising on critical and topical issues.
This book deals with the noteworthy advancement in the production of bioactive metabolites from microbes and their pharmacological significance. It highlights the pharmacological potential of marine microbes and endophytic fungi and their bioactive secondary metabolites. Emphasis is also given on the significance of probiotics and their specialized molecules in human health and disease as well as their role in dietary intervention for reducing the risk of non-alcoholic fatty liver disease. This work also serves as excellent reference material for researchers, students and academicians in the field of natural product chemistry, pharmacology and applied microbiology.
Nanofiber Composite Materials for Biomedical Applications presents new developments and recent advances in nanofiber-reinforced composite materials and their use in biomedical applications, including biomaterial developments, drug delivery, tissue engineering, and regenerative medicine. Unlike more conventional titles on composite materials, this book covers the most innovative new developments in nanofiber-based composites, including polymers, ceramics, and metals, with particular emphasis on their preparation and characterization methodology. Selected case studies illustrate new developments in clinical and preclinical use, making the information critical for the development of new medical materials and systems for use in human health care, and for the exploration of new design spaces based on these nanofibers. This book is essential reading for those working in biomedical science and engineering, materials science, nanoscience, biomedical nanotechnology, and biotechnology.
In this book, the authors discuss the principles, methodology and emerging challenges of drug development. Topics include outsourcing and technology transfer in pharmaceutical companies; analytical tools and chemometrics in the drug development process; the use of cytometry for drug development of cell cycling inhibitors; and the antiproliferative effects of phenolic compounds isolated from the Brazilian propolis.
Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.
Valuation is a hot topic among life sciences professionals. There is no clear understanding on how to use the different valuation approaches and how to determine input parameters. Some do not value at all, arguing that it is not possible to get realistic and objective numbers out of it. Some claim it to be an art. In the following chapters we will provide the user with a concise val- tion manual, providing transparency and practical insight for all dealing with valuation in life sciences: project and portfolio managers, licensing executives, business developers, technology transfer managers, entrep- neurs, investors, and analysts. The purpose of the book is to explain how to apply discounted cash flow and real options valuation to life sciences p- jects, i.e. to license contracts, patents, and firms. We explain the fun- mentals and the pitfalls with case studies so that the reader is capable of performing the valuations on his own and repeat the theory in the exercises and case studies. The book is structured in five parts: In the first part, the introduction, we discuss the role of the players in the life sciences industry and their p- ticular interests. We describe why valuation is important to them, where they need it, and the current problems to it. The second part deals with the input parameters required for valuation in life sciences, i.e. success rates, costs, peak sales, and timelines.
The only book to cover adhesion in pharmaceutical, biomedical and dental fields The phenomenon of adhesion is of cardinal importance in the pharmaceutical, biomedical and dental fields. A few eclectic examples will suffice to underscore the importance/relevance of adhesion in these three areas. For example, the adhesion between powdered solids is of crucial importance in tablet manufacture. The interaction between biodevices (e.g., stents, bio-implants) and body environment dictates the performance of such devices, and there is burgeoning research activity in modifying the surfaces of such implements to render them compatible with bodily components. In the field of dentistry, the modern trend is to shift from retaining of restorative materials by mechanical interlocking to adhesive bonding. The book contains 15 chapters written by internationally-renowned subject matter experts and is divided into four parts: Part 1: General Topics; Part 2: Adhesion in Pharmaceutical Field; Part 3: Adhesion in Biomedical Field; and Part 4: Adhesion in Dental Field. The topics covered include: Theories or mechanisms of adhesion; wettability of powders; role of surface free energy in tablet strength and powder flow behavior; mucoadhesive polymers for drug delivery systems; transdermal patches; skin adhesion in long-wear cosmetics; factors affecting microbial adhesion; biofouling and ways to mitigate it; adhesion of coatings on surgical tools and bio-implants; adhesion in fabrication of microarrays in clinical diagnostics; antibacterial polymers for dental adhesives and composites; evolution of dental adhesives; and testing of dental adhesive joints. Audience This book will be of great interest and considerable importance in materials science, physics and chemistry and R&D personnel in pharmaceutical, biomedical and dental arenas as well as practicing doctors and advanced graduate students carrying out research in these three disciplines.
Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement. Starting with an introduction to the subject and pharmacokinetics, it explores advances for such topics as oral, gastroretentive, intravitreal, and intrathecal drug delivery, as well as insulin delivery, gene delivery, and biomaterials-based delivery systems. It also describes drug delivery in cancer, cardiac, infectious diseases, airway diseases, and obstetrics and gynecology applications. Examining special clinical states requiring innovative drug delivery modifications, such as hypercoagulability often seen in pregnancy, cancer, and autoimmune diseases, the book also discusses methods for improved drug delivery in clinical settings using clinical end points, clinical trials, simulations, and other venues. It also describes the latest drug delivery advances involving nanomaterials, NEMS and MEMS devices, hydrogels, microencapsulation, lipids, stem cells, patches, and ultrasound. The book is rounded out by a chapter on the FDA regulatory and bioethical challenges involved in advancing drug delivery.
Industrial Applications of Marine Biopolymers presents different classes of marine biopolymers and their industrial applications, demonstrating the precious value of ocean resources to society. This timely volume discusses the exceedingly useful polymers derived from these materials that are biodegradable, biocompatible, and at times water soluble. Direct use or chemically modified forms of such biomaterials have many chemical sites, making them suitable for varied types of industrial applications. In addition, this book also addresses current global challenges of conservation, including extended drought conditions and the need for improved agricultural methods, together with new bio-medical developments. It is suitable for anyone who has an interest in the industrial applications of biopolymers.
This third edition volume expands on the previous editions both by presenting more detailed protocols for the techniques described in the first and second editions of High Throughput Screening: Methods and Protocols and by covering important new procedures. The first chapter of this book provides an overview of important assay development techniques, while the rest of the chapters detail how to develop and execute screens at whatever throughput the user needs. Some chapter examples are: structure-based virtual screening, high throughput screening using mass spectrometry, identification of state-dependent blockers for voltage gated calcium channels, bioluminescence resonance energy transfer platform to monitor protein-protein interactions in live cells, high throughput flow cytometry, and application of imaging-based assays in microplate formats for high content screening. Written in the highly successful Methods in Molecular Biology series format, 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. Cutting edge and thorough, High Throughput Screening: Methods and Protocols, Third Edition, is a valuable resource for anyone who is interested in HTS research.
This book comprehensively describes the development and practice of DNA-encoded library synthesis technology. Together, the chapters detail an approach to drug discovery that offers an attractive addition to the portfolio of existing hit generation technologies such as high-throughput screening, structure-based drug discovery and fragment-based screening. The book: Provides a valuable guide for understanding and applying DNA-encoded combinatorial chemistry Helps chemists generate and screen novel chemical libraries of large size and quality Bridges interdisciplinary areas of DNA-encoded combinatorial chemistry synthetic and analytical chemistry, molecular biology, informatics, and biochemistry Shows medicinal and pharmaceutical chemists how to efficiently broaden available chemical space for drug discovery Provides expert and up-to-date summary of reported literature for DNA-encoded and DNA-directed chemistry technology and methods
The second edition of Handbook of Essential Oils: Science, Technology, and Applications provides a much-needed compilation of information related to the development, use, and marketing of essential oils. It focuses particularly on the chemistry, pharmacology, and biological activities of essential oils, with contributions from a worldwide group of expert authorities on their historical, biological, regulatory, and biotransformation aspects. Features in the Second Edition: New chapters on the natural variability of components that often occurs in essential oils and on the natural processes that cause adulteration of essential oils Revisions, updates, and expansions of previous chapters Splits a previous chapter on biological activities of essential oils into two separate chapters on biological activities and antioxidative properties The book covers a wide range of areas applicable to essential oils research, including sources, production, analysis, storage, transport, chemistry, aromatherapy, pharmacology, toxicology, metabolism, technology, biotransformation, application, utilization, and trade. It includes discussions of biological activity testing, results of antimicrobial and antioxidant tests, and penetration-enhancing activities useful in drug delivery. A continuation of its preceding edition that features enhanced and expanded information, the second edition of Handbook of Essential Oils provides you with a broad and authoritative knowledge base in the study and use of essential oils.
This book reviews the advances and challenges of structure-based drug design in the preclinical drug discovery process, addressing various diseases, including malaria, tuberculosis and cancer. Written by internationally recognized researchers, this edited book discusses how the application of the various in-silico techniques, such as molecular docking, virtual screening, pharmacophore modeling, molecular dynamics simulations, and residue interaction networks offers insights into pharmacologically active novel molecular entities. It presents a clear concept of the molecular mechanism of different drug targets and explores methods to help understand drug resistance. In addition, it includes chapters dedicated to natural-product- derived medicines, combinatorial drug discovery, the CryoEM technique for structure-based drug design and big data in drug discovery. The book offers an invaluable resource for graduate and postgraduate students, as well as for researchers in academic and industrial laboratories working in the areas of chemoinformatics, medicinal and pharmaceutical chemistry and pharmacoinformatics.
This book investigates the relationship between phytoconstituents and properties in specific plants, such as Hibiscus rosa sinesis, Cuscuta reflexa, Citrullus colocynthis, Nardostachys jatamansi and Ocimum gratissimum, that are used in hair care products including shampoos, conditioners, dyes, and oils. It explains the impact of these materials on the growth, structure, appearance, and health of hair. It also explores how the chemistry of certain plants from sustainable sources is exploited for use in hair products and nutraceuticals. Additionally, the authors include information on ingredients used for formulating 'green' hair products that treat common conditions such as canities, dandruff and alopecia.
Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information Examines new technologies and strategies for improving biosimilar mAbs
From the Foreword Umberto Quattrocchi has brought us some amazing and useful works through the various dictionaries that he has compiled. This time it is for two very important plant families the palms and the cycads that are synthesized here in these two volumes. Each entry is fascinating not just for the botany and full nomenclature of the plant species but for all the associated uses, folklore and interactions with other organisms. ...These entries are fascinating glimpses of natural history. ... Botanists, conservationists, ethnobotanists, anthropologists, geographers, bird watchers, naturalists, historians and those of many other disciplines will find these volumes a most valuable and useful resource. It is the sort of book that will be in frequent use in my library. ----- Professor Sir Ghillean Prance FRS, VMH, Former Director, Royal Botanic Gardens, Kew Following the same format as Umberto Quattrocchi's highly praised and well-used previous works, The CRC World Dictionary of Palms: Common Names, Scientific Names, Eponyms, Synonyms, and Etymology brings together the vast and scattered literature on palms and cycads to provide better access to information on these economically important plants. Each genus and species has a detailed morphological description and includes a list of synonyms and vernacular names in many languages. Bibliographies accompany each entry which are comprehensive, up-to-date and multi-lingual. The detailed information for every entry on habitats, economic uses, historical and biographical data, botanical exploration, and linguistics will be useful for any library involved with botany, herbal medicine, pharmacognosy, medicinal and natural product chemistry, ecology, ethnobotany, systematics, general plant science, agriculture or horticulture. Umberto Quattrocchi is the author of the bestselling CRC World Dictionary of Plant Names, winner of the prestigious Hanbury Botanical Garden Award. His most recent multi-volume work, CRC World Dictionary of Medicinal and Poisonous Plants, received strong praise as being "... an unparalleled starting place-a tool of first resort for any thoughtful researcher. Quattrocchi and CRC have delivered a dictionary like no other, a learned finger pointing in the right direction." -John de la Parra, Northeastern University, Boston, Massachusetts, USA, from Economic Botany, Vol. 68, 2014
This brief explores recent progress in the area of polysaccharides and their composites and nanocomposites. It is a complete resource for the evolving field of polysaccharide based biomaterials and their applications in different fields. The volume focuses on their composition, properties, characterization, chemistry and applications and also highlights recent developments in polysaccharide based composites and nanocomposites spurred by advances in polymer technology and biotechnology. Divided into different sections featuring alginates, carrageenans, cellulose, starch, chitin, chitosan, gums, etc, each chapter presents chemical, physical, and biological attributes, and reviews the recent research performed such as drug carriers, selective water absorption materials from oil-water emulsions, purification of water, biomedical applications, etc. The authors hope that this brief will help to inspire scientists towards novel sources for chemicals, materials, and energy in the years to come.
As the world of biotechnology has grown in leaps and bounds, so too
have the career opportunities. But the choices can be daunting.
What types of jobs are available? How do you get your foot in the
door? What will your job entail if you become a "Preclinical
Project Manager" or a "Process Scientist"? What's the difference
between biotech and pharma?
This book offers deep insights into the thermodynamics and molecular structures of the twelve catalytically active isoforms of human carbonic anhydrase (CA) with a particular focus on inhibitor binding for drug design. X-ray crystallographic structures in combination with enzyme kinetic testing provide information on the interaction of CAs and their inhibitors, knowledge which is crucial for rational drug design. CAs are zinc carrying enzymes that catalyse the reversible interconversion of carbon dioxide and bicarbonate and are involved in numerous cellular processes. They are therefore a common target for drugs. The suppression of CA activities through inhibitory compounds has found application for example in diuretics and in glaucoma therapy. In this book methods used to determine binding thermodynamics of inhibitory compounds (Isothermal titration calorimetry, Fluorescent thermal shift assay/differential scanning fluorimetry and others) will be compared in detail. Also types and chemical synthesis of CA inhibitors, the use of antibodies against CAs as well as inhibitor application in animals are discussed.
The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.
This new volume focuses on the ever-growing and ever-sophisticated use of nanobiomaterials in drug delivery. There have been significant developments in the delivery of the active pharmaceutical ingredients to target sites, thereby sparing the normal functioning biological systems from damage, and this volume highlights some of the most important developments in the field. The book first provides an overview of nanobiomaterials and then goes on to report on new developments in drug delivery and nanotechnology, nanobiomaterials as carriers in cancer therapy, and the diverse uses of nanobiomaterials. Broken into sections, the chapters cover: an overview of nanobiomaterials drug delivery and nanotechnology nanobiomaterials as carriers in cancer therapeutics diverse uses of nanobiomaterials This volume will be a valuable resource on drug delivery for pharmaceutical manufacturers, healthcare personnel, and researchers.
From crystal structure prediction to totally empirical screening, the quest for new crystal forms has become one of the most challenging issues in the solid state science and particularly in the pharmaceutical world. In this context, multi-component crystalline materials like co-crystals have received renewed interest as they offer the prospect of optimized physical properties. As illustrated in this first book_ entirely dedicated to this emerging class of pharmaceutical compounds_ the outcome of such endeavours into crystal engineering have demonstrated clear impacts on production, marketing and intellectual property protection of active pharmaceutical ingredients (APIs). Indeed, co-crystallization influences relevant physico-chemical parameters (such as solubility, dissolution rate, chemical stability, melting point, hygroscopicity, a) and often offers solids with properties superior to those of the free drug. Combining both reports of the latest research and comprehensive overviews of basic principles, with contributions from selected experts in both academia and industry, this unique book is an essential reference, ideal for pharmaceutical development scientists and graduate students in pharmaceutical science."
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