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Author: Manmohan Singh
Publisher: Springer Science & Business Media
ISBN: 1461453801
Category : Medical
Languages : en
Pages : 369
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Book Description
Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations—many of which will be nanoparticulates—can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.
Author: Manmohan Singh
Publisher: Springer Science & Business Media
ISBN: 1461453801
Category : Medical
Languages : en
Pages : 369
Get Book Here
Book Description
Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations—many of which will be nanoparticulates—can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.
Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 1118874080
Category : Science
Languages : en
Pages : 568
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Book Description
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Author: Daan J. A. Crommelin
Publisher: CRC Press
ISBN: 9780415285018
Category : Medical
Languages : en
Pages : 456
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Book Description
The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.
Author: Sandip V. Pawar
Publisher: Springer Nature
ISBN: 9813362367
Category : Medical
Languages : en
Pages : 367
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Book Description
In a normal physiological state, several bacteria are present in the human gut that is essential to maintain the normal to healthy gastrointestinal function. Disturbances in this “normal flora” lead to gut inflammation and infection. This volume explores the potential of probiotics, the healthy bacteria, to manage gut-related diseases including gastrointestinal cancers, ulcerative colitis, H. pylori infections, and diarrhea; vaginosis; oral health; airway inflammation; and atopic dermatitis. The concept of designer probiotics, edible vaccines and future scope of research in the field is also presented. The animal models used for studying the benefits of probiotics in gut inflammation are described for beginners.
Author: Anil K. Sharma
Publisher: CRC Press
ISBN: 1351792458
Category : Medical
Languages : en
Pages : 550
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Book Description
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.
Author:
Publisher: Elsevier
ISBN: 0081006128
Category : Science
Languages : en
Pages : 8639
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Book Description
Comprehensive Toxicology, Third Edition, Fifteen Volume Set discusses chemical effects on biological systems, with a focus on understanding the mechanisms by which chemicals induce adverse health effects. Organized by organ system, this comprehensive reference work addresses the toxicological effects of chemicals on the immune system, the hematopoietic system, cardiovascular system, respiratory system, hepatic toxicology, renal toxicology, gastrointestinal toxicology, reproductive and endocrine toxicology, neuro and behavioral toxicology, developmental toxicology and carcinogenesis, also including critical sections that cover the general principles of toxicology, cellular and molecular toxicology, biotransformation and toxicology testing and evaluation. Each section is examined in state-of-the-art chapters written by domain experts, providing key information to support the investigations of researchers across the medical, veterinary, food, environment and chemical research industries, and national and international regulatory agencies. Thoroughly revised and expanded to 15 volumes that include the latest advances in research, and uniquely organized by organ system for ease of reference and diagnosis, this new edition is an essential reference for researchers of toxicology. Organized to cover both the fundamental principles of toxicology and unique aspects of major organ systems Thoroughly revised to include the latest advances in the toxicological effects of chemicals on the immune system Features additional coverage throughout and a new volume on toxicology of the hematopoietic system Presents in-depth, comprehensive coverage from an international author base of domain experts
Author: Camilla Foged
Publisher: Springer
ISBN: 1493914170
Category : Medical
Languages : en
Pages : 433
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Book Description
This comprehensive volume compiles the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. Twenty-one chapters are divided into four main parts: (I) Background; (2) Delivery Systems for Subunit Vaccines; (3) Delivery Routes, Devices and Dosage Forms; and (4) Pharmaceutical Analysis and Quality Control of Vaccines. Part one provide a basic background with respect to immunology and general vaccine classification. In part two, it presents representative types of vaccine delivery systems individually with focus on the physicochemical properties of the systems and their significance for the immune response they stimulate. These delivery systems include aluminum adjuvants, emulsions, liposomes, bilosomes, cubosomes/hexosomes, ISCOMs, virus-like particles, polymeric nano- and microparticles, gels, implants and cell-based delivery systems. Following these chapters, part three addresses the challenges associated with vaccine delivery via specific routes of administration—in particular subcutaneous, intramuscular, oral, nasal, pulmonary, transdermal and vaginal administration. Furthermore, the specific administration routes are discussed in combination with device technologies relevant for the respective routes as well as dosage forms appropriate for the device technology. Finally, the fourth part concerns pharmaceutical analysis and quality control of subunit vaccines.
Author: Virgil Schijns
Publisher: Elsevier
ISBN: 0080457215
Category : Medical
Languages : en
Pages : 396
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Book Description
Immunopotentiators in Modern Vaccines provides an in-depth insight and overview of a number of most promising immunopotentiators in modern vaccines. In contrast to existing books on the subject it provides recent data on the critical mechanisms governing the activity of vaccine adjuvants and delivery systems. Knowledge of immunological pathways and scenarios of the cells and molecules involved is described and depicted in comprehensive illustrations. - Contributions from leading international authorities in the field - Well-illustrated, informative figures present the interactions between immunopotentiators and the host immune system - Each chapter lists advantages and potential hurdles for achieving a practical application for the specific immunopentiator
Author: Joy A. Cavagnaro
Publisher: CRC Press
ISBN: 1000471853
Category : Medical
Languages : en
Pages : 952
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Book Description
Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Author: Lisa M. Plitnick
Publisher: Elsevier
ISBN: 044313345X
Category : Medical
Languages : en
Pages : 484
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Book Description
Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. A multi-edited book with chapters authored by leading qualified experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late-stage biologics. - Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical - Discusses the most pertinent international regulatory guidelines - Covers early derisking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines
