Biologics in General Medicine, W.-H. Boehncke; H.H. Radeke
Автор: Baldo Название: Safety of Biologics Therapy ISBN: 3319304704 ISBN-13(EAN): 9783319304700 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.
Автор: Dushyant Varshney; Manmohan Singh Название: Lyophilized Biologics and Vaccines ISBN: 149392382X ISBN-13(EAN): 9781493923823 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Preface.- Part I - Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles.- New Developments in Controlled Nucleation: Commercializing VERISEQ(R) Nucleation technology.- Part II - Lyophilized Biologics and Vaccines - Modality Considerations.- Lyophilized Biologics.- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design.- Advances in Process Analytical Technology in Freeze Drying.- Process Scale-up and Optimization of Lyophilized Vaccine Products.- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations.- Part III - Advances in Alternate Drying.- Alternatives to Vial Lyophilization.- Spray Drying of Biopharmaceuticals.- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals.- Case Studies and Examples of Biopharmaceutical Modalities.- Processed by Bulk Crystallization or Bulk Freeze Drying.- Part IV- Regulatory, Packaging and Technology Transfer Considerations.- Lyophilization of Biologics - An FDA Perspective.- Recent Trends in Lyophilized Delivery Devices and Packaging.- Lyophilization Technology Transfer towards Product Launch.
Автор: Dushyant Varshney; Manmohan Singh Название: Lyophilized Biologics and Vaccines ISBN: 1493955683 ISBN-13(EAN): 9781493955688 Издательство: Springer Рейтинг: Цена: 16070.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: * Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations * Details the latest developments in instrumental analysis and controlled ice nucleation technology * Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics * Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective * Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies * Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.
Автор: Yamauchi Название: Biologic and Systemic Agents in Dermatology ISBN: 3319668838 ISBN-13(EAN): 9783319668833 Издательство: Springer Рейтинг: Цена: 25155.00 р. Наличие на складе: Поставка под заказ.
Описание: Written by leading experts in the field and designed for dermatologists and residents, this book includes evidence-based medicine that underscores the clinical data, as well as practical tips on how to use both biologic and systemic agents in the field of dermatology. In the past decade, there have been several groundbreaking advances in medical dermatology. Novel biologic and systemic agents have been developed to treat inflammatory disorders, including psoriasis and atopic dermatitis, as well as skin malignancies such as melanoma. Biologic and Systemic Agents in Dermatology encompasses these developments by describing the mechanism of action of these various agents and the clinical efficacy and safety to treating these respective disorders. The utilization of biologic and systemic agents in other dermatologic conditions, pharmacoeconomics, pharmacovigilance, and clinical trials outcomes are discussed as well as topics including tumor necrosis, conventional systemic agents for psoriatic disease, and oral agents for atopic dermatitis.
Описание: Integrating Population Outcomes, Biological Mechanisms and Research Methods in the Study of Human Milk and Lactation is the product of the 10th Conference of the International Society for Research on Human Milk and Lactation, held on September 15-19, 2000, in Tucson, Arizona.
Автор: Marek Jankowski; Tomasz Wandtke; Marta Jakubowska Название: Interleukin-27: Biological Properties and Clinical Application ISBN: 3319396625 ISBN-13(EAN): 9783319396620 Издательство: Springer Рейтинг: Цена: 9141.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Also covered are the conflicting reports on the role of IL-27 in rheumatoid arthritis, the effect of IL-27 on epithelia, which seems to play a role in asthma, psoriasis and inflammatory bowel diseases, and the direct cytotoxic and anti-vascular effects of IL-27, which make it a promising agent for the treatment of cancer.
Описание: This book discusses the relationship between cellular immunity and tryptophan metabolism, as well as its products, serotonin and melatonin, in the development of several diseases and reappraises the common signal transduction pathways of the neurodegenerative diseases, carcinogenesis, immune tolerance, inflammation, hypersensitivity reactions, neuropsychiatric disorders, in addition to bacterial tryptophan biosynthesis and novel antimicrobials. Tryptophan Metabolism: Implications for Biological Processes, Health and Disease presents fundamental information on tryptophan related metabolic pathways and metabolites, implications of these products for specific biological processes, diseases and conditions. This book focuses on effects of tryptophan metabolites on human health and will appeal to researchers, clinicians and students within this field.
Автор: Van Vollenhoven, Ronald Название: Biologics for the treatment of rheumatoid arthritis ISBN: 3319131079 ISBN-13(EAN): 9783319131078 Издательство: Springer Рейтинг: Цена: 8384.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a comprehensive overview of the available biologic therapies whilst comparing them to standard disease modifying anti-rheumatic drugs, and discusses how best to determine which therapy is most appropriate for an individual patient in the framework of current guidelines.
Автор: Andor Szentivanyi Название: Biological Response Modifiers in Human Oncology and Immunology ISBN: 1475714122 ISBN-13(EAN): 9781475714128 Издательство: Springer Рейтинг: Цена: 16979.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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