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Biosimilars And Interchangeable Biologics

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9781138775503
Size: 76.93 MB
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What's the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Biosimilars And Interchangeable Biologics

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1498743501
Size: 74.76 MB
Format: PDF, Kindle
View: 237
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What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

Biosimilar And Interchangeable Biologics

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9781482298918
Size: 43.98 MB
Format: PDF, ePub
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The field of biosimilar drugs is one of the hottest subjects in the filed of new drug development, with scores of companies offering seminar and training programs for prospective manufacturers and stakeholders. This book is a modern comprehensive overview of the entire biosimilar manufacturing and distribution process, covering concepts introduced by the FDA, litigation strategies, analytical methods, pharmokinetic studies, and the future and current status of biosimilar product approvals.

Biosimilar Clinical Development Scientific Considerations And New Methodologies

Author: Kerry B. Barker
Publisher: CRC Press
ISBN: 1482231700
Size: 51.56 MB
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Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

Safety Of Biologics Therapy

Author: Brian A. Baldo
Publisher: Springer
ISBN: 3319304720
Size: 21.54 MB
Format: PDF, ePub
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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.

Applied Molecular Biotechnology

Author: Muhammad Sarwar Khan
Publisher: CRC Press
ISBN: 1498714838
Size: 60.33 MB
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Applied Molecular Biotechnology: The Next Generation of Genetic Engineering explains state-of-the-art advances in the rapidly developing area of molecular biotechnology, the technology of the new millennium. Comprised of chapters authored by leading experts in their respective fields, this authoritative reference text: Highlights the latest omics-based tools and approaches used in modern biotechnology Explains how various molecular biology technologies can be used to develop transgenic plants and how those plants can meet growing food and plant-derived product demands Discusses chloroplast gene expression systems, mitochondrial omics, plant functional genomics, and whole-genome resequencing for crop improvement Explores plant–microbe and plant–insect interactions affecting plant protection and productivity Covers animal models, pharmacogenomics, human tissue banking, and the molecular diagnosis of diseases such as cervical cancer, obesity, and diabetes Examines the molecular aspects of viral diseases, production of industrial commodities using viral biotechnology, and biotechnological uses of magnetic nanoparticles Describes the use of biotechnology in the food, chemical, pharmaceutical, environmental conservation, and renewable energy sectors Applied Molecular Biotechnology: The Next Generation of Genetic Engineering serves as a springboard for new discoveries in molecular biology and its applications. Thus, this book is an invaluable resource for students and researchers of molecular biotechnology.

The Elements Of Applied Psychological Practice In Australia

Author: Nadine Pelling
Publisher: Psychology Press
ISBN: 1317354656
Size: 47.91 MB
Format: PDF, ePub, Docs
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The Elements of Applied Psychological Practice in Australia is a comprehensive and applied review of material required for basic psychological practice in Australia. This book is the first of its kind to offer a one-step resource to success in the Australian National Psychology Examination. Nadine Pelling and Lorelle Burton have provided you with everything you need and more, most notably: • A comprehensive review of applied areas and all assessments noted as important by the Psychology Board of Australia • Study skills and tips, including ‘making a study plan’ and how to manage your time • 100 sample Multiple Choice Questions (MCQ) with answers and explanations. For anyone looking to take the Australian National Psychology Examination, this detailed, concise, and extremely easy to read book is an absolute must-have. Beginning-level and experienced psychologists will also find the comprehensive coverage of applied practice areas a useful reference for their client-related work, and its value as a resource comes alive with its succinct presentation of client-based psychological assessment and the ethics of applied practice and interventions. This book will also be of interest to teachers of psychology and international psychologists and scholars who may be interested in how psychology is practiced in Australia.

Basic Principles Of Analytical Ultracentrifugation

Author: Peter Schuck
Publisher: CRC Press
ISBN: 1498751164
Size: 45.65 MB
Format: PDF
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Analytical ultracentrifugation (AUC) can supply rich information on the mass, shape, size distribution, solvation, and composition of macromolecules and nanoscopic particles. It also provides a detailed view of their reversible single- or multi-component interactions over a wide range of affinities. Yet this powerful technique has been hard to master in mainstream molecular sciences due to a lack of comprehensive books on the subject. Filling this gap in the literature of biophysical methodology, Basic Principles of Analytical Ultracentrifugation explains the fundamentals in the theory and practice of AUC. The book provides you with up-to-date experimental information to confidently practice AUC. You will understand the basic concepts, full potential, and possible pitfalls of AUC as well as appreciate the current relevance of past work in the field. The book first introduces the basic principles and technical setup of an AUC experiment and briefly describes the optical systems used for detection. It then explores the ultracentrifugation experiment from a macromolecular standpoint, offering a detailed physical picture of the sedimentation process and relevant macromolecular parameters. The authors present important practical aspects for conducting an experiment, including sample preparation, data acquisition and data structure, and the execution of the centrifugal experiment. They also cover instrument calibration and quality control experiments.

Biosimilar Drug Product Development

Author: Laszlo Endrenyi
Publisher: CRC Press
ISBN: 9781498718790
Size: 56.76 MB
Format: PDF, Mobi
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When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Developmentpresents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Biosimilars

Author: Jean-Louis Prugnaud
Publisher: Springer Science & Business Media
ISBN: 2817803361
Size: 71.76 MB
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Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.