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Book
Fast Facts : Biosimilars
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ISBN: 1910797685 Year: 2018 Publisher: Abingdon, Oxford, England : Health Press Ltd,

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Abstract

Biosimilars have been in clinical use for more than 10 years, and evidence from more than 700 million patient-days’ exposure shows that approved biosimilars can be used as safely and effectively as their originator biologics. And yet concerns about these drugs persist, particularly in therapy areas where they are recent additions to the formulary. It is vital to address these concerns so that clinicians can prescribe biosimilars with confidence, realizing substantial cost savings and improving patient access to effective treatments. 'Fast Facts: Biosimilars' provides a comprehensive yet concise explanation of biosimilars: what they are, how they are regulated, and how they are used in clinical practice. It is ideal for healthcare professionals and decision makers who want to understand biosimilars and the key concerns and controversies around these valuable products. Contents: 1 - An introduction to biologics and biosimilars 2 - Why do we need biosimilars? 3 - How is the quality of biosimilars assured? 4 - How is the efficacy and safety of biosimilars ensured? 5 - What has been the experience with biosimilars to date? 6 - The future of biosimilar medicines 7 - How do I use biosimilar medicines?


Book
Modern applications of plant biotechnology in pharmaceutical sciences
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ISBN: 0128024984 0128022213 9780128024980 9780128022214 Year: 2015 Publisher: Amsterdam, [Netherlands] : Academic Press,

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Modern Applications of Plant Biotechnology in Pharmaceutical Sciences explores advanced techniques in plant biotechnology, their applications to pharmaceutical sciences, and how these methods can lead to more effective, safe, and affordable drugs. The book covers modern approaches in a practical, step-by-step manner, and includes illustrations, examples, and case studies to enhance understanding. Key topics include plant-made pharmaceuticals, classical and non-classical techniques for secondary metabolite production in plant cell culture and their relevance to pharmaceutical science...


Book
Microfluidics for pharmaceutical applications
Authors: --- ---
ISBN: 9780128126608 0128126604 9780128126592 0128126590 Year: 2019 Publisher: Amsterdam, Netherlands

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"Microfluidics for Pharmaceutical Applications: From Nano/Micro Systems Fabrication to Controlled Drug Delivery is a concept-orientated reference that features case studies on utilizing microfluidics for drug delivery applications. It is a valuable learning reference on microfluidics for drug delivery applications and assists practitioners developing novel drug delivery platforms using microfluidics. It explores advances in microfluidics for drug delivery applications from different perspectives, covering device fabrication, fluid dynamics, cutting-edge microfluidic technology in the global drug delivery industry, lab-on-chip nano/micro fabrication and drug encapsulation, cell encapsulation and delivery, and cell- drug interaction screening"--Publisher.


Book
Pharmaceutical biotechnology : a programmed text
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ISBN: 0877629110 Year: 1992 Publisher: Lancaster Technomic

Medical biotechnology : achievements, prospects and perceptions
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ISBN: 9280811142 1423765974 9280870955 9781423765974 9789280811148 9789280870954 Year: 2005 Publisher: Tokyo ; New York : United Nations University Press,

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For many people, biotechnology means genetically modifi ed organisms, alien species, toxic weapons or hormone-treated beef. Yet it is also a tool to control plant and animal pests, pre-serve species, utilize genetic resources for health and nutrition and protect the environment. Society's ability to manage, share and regulate advanced biotechnology offers many opportu-nities and raises many challenges and risks.This book explores the issues of advanced biotechnology and examines the progress made in recent years. It looks at the drivers of medical and pharmaceutical biotechnology develop-ment


Book
Plant Molecular Farming
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ISBN: 9783031127946 Year: 2022 Publisher: Cham Springer International Publishing :Imprint: Springer


Book
Phytochemical nanodelivery systems as potential biopharmaceuticals
Authors: --- --- --- ---
ISBN: 0323904157 9780323903905 0323903908 9780323904155 Year: 2023 Publisher: Amsterdam, Netherlands Oxford, United Kingdom Cambridge MA

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Phytochemical Nanodelivery Systems as Potential Biopharmaceuticals comprehensively reviews current information on nanotechnology applied to phytochemical nanoencapsulation to enhance their bioavailability and bioactivity. The book is divided into two sections, the first section critically reviews current information on the field of nanotechnology and phytochemicals, and the second section highlights the pre-clinical and clinical studies of phytochemicals to comprehensively review the efficacy of these molecules as drugs of human use. Phytochemical Nanodelivery Systems as Potential Biopharmaceuticals provides a useful overview of this rapidly evolving field for materials scientists and pharmaceutical scientists, as well as for those with an interest in biopharmaceuticals from plant sources, such as organic chemists and food scientists. Provides an introduction to both phytochemicals and nanomaterials for use in biopharmaceutics, allowing both materials scientists and pharmaceutical scientists to gain a basic understanding of each field Reviews key phytochemical types for use as biopharmaceuticals, including terpenes, alkaloids, glucosinolates and more Explores the various nanomaterials and nanoencapsulation techniques for administration of phytochemical nanoformulations.


Book
Genomic biomarkers for pharmaceutical development
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ISBN: 0123977940 0123973368 1299738885 9780123977946 9780123973368 Year: 2014 Publisher: San Diego, Calif. Academic Press

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Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, to


Book
Challenges in delivery of therapeutic genomics and proteomics
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ISBN: 1282879642 9786612879647 0123849659 0123849640 9780123849649 9780123849656 Year: 2010 Publisher: Oxford Elsevier

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Delivery of therapeutic proteomics and genomics represent an important area of drug delivery research. Genomics and proteomics approaches could be used to direct drug development processes by unearthing pathways involved in disease pathogenesis where intervention may be most successful. This book describes the basics of genomics and proteomics and highlights the various chemical, physical and biological approaches to protein and gene delivery. Covers a diverse array of topics from basic sciences to therapeutic applications of proteomics and genomics delivery<


Book
Challenges in Protein Product Development
Authors: ---
ISBN: 3319906038 3319906011 Year: 2018 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

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