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Active botanical ingredients are a prime requirement for herbal formulations and discovering a drug is all about integration of science disciplines. In recent decades there has been a growing interest in treating wounds and diseases using traditional remedies based on local herbs, combined with chemical advances. Although this has led to the development of new bioactive ingredients from plants, there has been little success in terms of clinical trials and post-marketing studies to comply with FDA guidelines. Plants have been used as a source of medicine throughout history and continue to serve as the basis for many pharmaceuticals used today. However, despite the modern pharmaceutical industry being founded on botanical medicine, synthetic approaches to drug discovery have now become standard. Science-driven translational discovery and botanical development has created a new reality, leading to enormous changes in strategies, technologies and the disciplines involved, which have been embraced by the pharmaceutical and biotech industries. This book gathers scientific expertise and traditional knowledge to promote the discovery and development of new formulations and drugs based on active ingredients and to provide guidance on taking these to clinical trials. It discusses major topics, such as how the phytochemical composition of many plants has changed over time due to factors like cultivation, which can have both positive and negative effects on the levels of bioactive compounds. It also explores the importance of plants as a valuable source of therapeutic compounds as a result of their vast biosynthetic capacity, and classifies them according to their intended use, safety and regulatory status. Further, the book offers insights into the regulatory aspects of botanical products, which is an important issue when considering standardization and quality assessment, and also examines the commercial aspects of plant-derived medications and their proven role in the treatment of chronic diseases such as heart disease, high blood pressure, pain, asthma, and other associated conditions. Given its scope, this book is a valuable tool for botanists, natural product chemists, pharmacologists and microbiologists involved in the study of phytochemicals for drug discovery. .
Pharmacology. Therapy --- resistentie (farmacologie) --- geneesmiddelentolerantie --- farmacologie
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At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.
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Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic “Pharmaco-complexity: Non-linear Phenomena and Drug Product Development”.
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This book focuses on the application of nanotechnology to deliver drugs and biological agents by the mucosal routes of administration i.e. nasal, pulmonary, buccal, and oral routes.It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery. Mucosal Delivery of Drugs and Biologics in Nanoparticles emphasize the use of nanoparticles in treating various cancers and infectious diseases. It broadens the use of nanoparticles by including biologics, including vaccines and immunotherapies, apart from drugs. It acknowledges the concerns around the potential toxicity of nanoparticles to the host; few chapters will discuss the biodistribution of these nanoparticles when mucosal routes of administration are employed. Further, the interaction of nanoparticles with the host’s immune cells is discussed. Moreover,it reviews the regulatory aspects of nanotechnology in product development, especially when delivered by the mucosal route of administration. Lastly, discusses the challenges and opportunities to manufacture nanoparticles on an industrial scale. This book will be the first of its kind to focus on the design, development and delivery of nanoparticles when administered by different mucosal routes.
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The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials). Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout. The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. .
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Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology. .
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General microbiology --- Pharmacology. Therapy --- resistentie (farmacologie) --- geneesmiddelentolerantie --- farmacie --- farmacologie --- microbiologie
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Antimicrobial resistance is a major global public health problem. This book focuses on the clinical implications of multi-drug resistant pathogens; tracking AMR and its evolutionary significance; antifungal resistance; and current and alternative treatment strategies for AMR, including antivirulent, antibiofilm and antimicrobial resistance breakers, repurposing of drugs, and probiotic therapy. Advances in antimicrobial stewardship, antibiotic policies from a global perspective and their impacts are also discussed. The book also explores the use of omics approaches to gain insights into antibacterial resistance, and includes chapters on the potential benefits of a ‘One Health approach’ describing the environmental and zoonotic sources of resistant genes and their effects on the global resistance pool. .
General microbiology --- Pharmacology. Therapy --- resistentie (farmacologie) --- geneesmiddelentolerantie --- farmacie --- farmacologie --- microbiologie
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Pharmacology. Therapy --- Nursing --- farmacologie --- verpleegkunde
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