Автор: Ranjita Shegokar Название: Viral Drug Delivery Systems ISBN: 3031205391 ISBN-13(EAN): 9783031205392 Издательство: Springer Рейтинг: Цена: 20733.00 р. Наличие на складе: Нет в наличии.
Описание: The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future, primarily due to increased longevity that almost always comes at a cost of impaired immunity.A total of four books are covered under the series of Infectious drug diseases.- Malarial drug delivery systems- Tubercular drug delivery systems- Viral drug delivery systems- Infectious disease drug delivery systemsThe third volume of series is focused on viral drug delivery systems. Typically, virus attaches to the cells (referred as host cell) and releases its DNA or RNA inside the cell. In second stage, virus’s genetic material takes control of the cell and forces it to replicate the virus leading to onset of disease symptoms. DNA class of viruses include Herpes, Papilloma and Adeno viruses. RNA class of viruses include retroviruses, such as HIV immunodeficiency virus and SARS COV – 2 / Corona virus. This book addresses recent developments in viral drug delivery systems. It covers many different aspects of viral infections, ways to treat them using modern drug delivery systems like nano particulate carriers. The choice of viral delivery systems mainly depends upon the type of virus, duration of life cycle, presence of drug resistance, cellular and mucosal interaction of virus, accordingly gene or non-gene drug delivery systems are selected. Besides that, this book also reports global dynamics of viral diseases, future predictions of infection rate, current treatment options, details of drug carriers like nanoemulsions, polymeric nanoparticles, role of biofunctionalization, and phyto-molecules in treatment of viral infections particularly herpes, Covid-19, Ebola, HIV/AIDS, influenza and viral hepatitis.Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of viral drug delivery research.
Описание: Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but incan readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Описание: The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms.Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process.Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations.Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up.Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource forthose involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.
Автор: Krauss Brendon Название: Pharmaceutics: Science and Technology ISBN: 1682862127 ISBN-13(EAN): 9781682862124 Издательство: Неизвестно Цена: 24943.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceutics is one of the most significant sub-fields of pharmaceutical sciences. Discovery of new and more efficient drugs has been the focus of numerous researches worldwide. This book collates such researches conducted by internationally renowned experts. It delves deep into the areas of drug conception, drug classification and manufacturing. This extensive text will help students and pharmacologists across the globe in keeping pace with the rapid developments in this field.
Автор: Ajay Babu Pazhayattil Название: Technology Transfer ISBN: 3031322193 ISBN-13(EAN): 9783031322198 Издательство: Springer Рейтинг: Цена: 12196.00 р. Наличие на складе: Нет в наличии.
Описание: Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.
Автор: Brunaugh Название: Essential Pharmaceutics ISBN: 3031525191 ISBN-13(EAN): 9783031525193 Издательство: Springer Рейтинг: Цена: 12196.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Particularly in healthcare fields, there is a growing movement away from traditional lecture style courses towards active learning and team-based activities to improve retention of concepts and build higher level thinking through the application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style and is the first book of its kind of provide the resources and skills needed for the successful implementation of an active learning basic pharmaceutics course. This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Essential Pharmaceutics provides the requisite foundational knowledge for the development and implementation of case studies based upon modern drug products.
Название: Modern Pharmaceutics ISBN: 1841847739 ISBN-13(EAN): 9781841847733 Издательство: Taylor&Francis Рейтинг: Цена: 14240.00 р. Наличие на складе: Нет в наличии.
Автор: Krauss Brendon Название: Pharmaceutics: Concepts and Applications ISBN: 1632423189 ISBN-13(EAN): 9781632423184 Издательство: Неизвестно Цена: 24783.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Heather Murphy Название: A Guide to Pharmacovigilance Audits in the USA ISBN: 3031735951 ISBN-13(EAN): 9783031735950 Издательство: Springer Рейтинг: Цена: 17074.00 р. Наличие на складе: Нет в наличии.
Описание: Pharmacovigilance Audits are an important and growing requirement for Pharmaceutical/BioTech companies. A niche skillset combined with an understanding of audit principles and pharmacovigilance operational and regulatory knowledge are required to effectively conduct these audits This book provides practical guidance to auditors as to what questions to ask, what information to look for, and what documents to request to ensure the auditee Pharmacovigilance System is compliant with regulations, contractual requirements, and industry best practice. The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.
Автор: Dimitrios Lamprou Название: Nano- and Microfabrication Techniques in Drug Delivery ISBN: 3031269101 ISBN-13(EAN): 9783031269103 Издательство: Springer Рейтинг: Цена: 28051.00 р. Наличие на складе: Нет в наличии.
Описание: New materials and manufacturing techniques are evolving with the potential to address the challenges associated with the manufacture of medicinal products that will teach new tricks to old drugs. Nano- and microfabrication techniques include manufacturing methods such as additive manufacturing, lithography, micro-moulding, spray drying, and supercritical fluids among many others. The increasing resolution of new techniques allow researchers to produce objects with micrometric resolutions. This book follows a consecutive order, beginning with a background in the current field and limitations in the manufacturing of different pharmaceutical products, moving on the classification of each method by providing recent examples, and future prospective on a variety of traditional and new Nano and microfabrication techniques. A focus on the materials used to prepare these systems and their biocompatibility, including applied topics such as clinical applications and regulatory aspects also covered, offering the reader a holistic view of this rapidly growing field.
Описание: This book is a comprehensive coverage of the ubiquitin-proteasome system and its involvement in cancer progression, and the application of PROTACs in different types of cancer treatment. The book discusses a unique perspective and comprehensive knowledge of the potential of PROTACs to transform cancer therapies. It provides an overview of the history, mechanisms, chemistry, design considerations, and different technologies involved in PROTACs. Additionally, it explains the ubiquitin-proteasome system, its impact on various diseases, and the principles and mechanisms of UPS. The book also describes the chemistry and design aspects of PROTACs and their role in various types of cancers. Finally, it covers the pharmaceutics aspect of formulation design, global requirements, and toxicological aspects of PROTACs. This book is targeted at cancer researchers, medical oncologists, bioinformatics, computational biologists, pharmacologists, medicinal chemists, formulation scientists, regulatory authorities, and policy makers.
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