biosimilars and interchangeable biologics strategic elements

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Biosimilars And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 9781498743488
Genre : Medical
File Size : 41. 95 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
ISBN : 9781498743501
Genre : Medical
File Size : 90. 20 MB
Format : PDF, Docs
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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 Clinical Development Scientific Considerations And New Methodologies

Author : Kerry B. Barker
ISBN : 9781482231700
Genre : Mathematics
File Size : 46. 27 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.

25days

Author : Drew Logan
ISBN : 9781501162992
Genre : Health & Fitness
File Size : 51. 41 MB
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Celebrity trainer and cast member of NBC’s Strong, Drew Logan shows us how to rewrite our neurological patterns and break the habits that prevent us from losing weight and living a healthy life. What if we could train our brains to stop weight gain in our quest to be lean, healthy, and fit? Well, we can. Celebrity trainer and cast member of NBC’s Strong, Drew Logan knows firsthand how the brain affects our ability to perform and function at our best. After dying three times in three hours—becoming the world’s only known medical case to survive three sudden cardiac arrests—he lost his short-term memory. He could no longer follow the complicated diet and fitness regimens he’d used on himself and his clients. He needed to create something simpler. He was shocked to discover that the resulting program was even more effective than his complicated regime of the past. In 25 Days, Drew outlines a unique, multifaceted approach that helps readers rewrite their neurological patterning—what lies underneath those pesky habits that get in our way over and over again—so that the brain’s neural pathways, biochemistry, and hormones work together effectively, seamlessly, and efficiently. He defines what neurological patterns are, how they form, and the reason they’re secretly behind why most people fail to lose weight and get in shape. He breaks down these “unhealthy” patterns and shows how to erase them by creating healthier ones with diet, exercise, and a reward system. Included in the book are the 25 Days Grading System, Diet, and Workout Plan, as well as tools that will alert and assist readers throughout the book. 25 Days is one of the easiest—and effective—diets to follow, and Drew will show you that all you need is to adjust your diet and retrain your brain to be in peak shape.

Biosimilar And Interchangeable Biologics

Author : Sarfaraz K. Niazi
ISBN : 1482298910
Genre : Medical
File Size : 46. 15 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.

Measurement Of Soft Tissue Elasticity In Vivo

Author : Yan-Ping Huang
ISBN : 9781466576292
Genre : Medical
File Size : 46. 29 MB
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The product of 20 years of research, this book covers topics in soft tissue elasticity in vivo, from measurement techniques to clinical applications. It provides, for the first time, a single source that systematically introduces the various techniques for in vivo measurement of soft tissue elasticity in an effort to ease the difficulty between learning technical details and clinical applications of techniques. Measurement of Soft Tissue Elasticity in Vivo: Techniques and Applications presents an overview of the existing measurement methods, their physical principles, assumptions, advantages, and disadvantages. Clinical applications discussed include assessment of tissue fibrosis after radiotherapy, articular cartilage degeneration, muscle contraction, cancer staging, liver fibrosis progression, diabetic foot ulceration, cornea stiffening, and wound healing. Techniques covered include shear wave propagation methods, vibro-ultrasound methods, dynamic holography, ultrasound and other indentation methods, and OCT-based and other suction measurement methods. The book also proposes two critical directions for future research in the field. One is to standardize the terms, parameters, and test protocols used in different fields. The second proposal is to standardize one technique to dominate the field, while devices can be adapted to fit the measuring requirements of different tissues. In doing so, the results obtained for the same tissue by different clinicians can be comparable and a standardized protocol can be established. This book bridges the gap between the complexity of measuring techniques and simplicity and accuracy of their clinical use. Its comprehensiveness and clarity help new engineers in the field develop analytical methods and allow clinicians to use these techniques in their practice with greater confidence.

Safety Of Biologics Therapy

Author : Brian A. Baldo
ISBN : 9783319304724
Genre : Medical
File Size : 25. 98 MB
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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.

Biosimilar Drug Product Development

Author : Laszlo Endrenyi
ISBN : 9781498718806
Genre : Medical
File Size : 68. 44 MB
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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 Development presents 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.

The Complete Guide To Fertility Awareness

Author : Jane Knight
ISBN : 9781317654216
Genre : Medical
File Size : 32. 4 MB
Format : PDF, Docs
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Fertility Awareness is key to understanding sexual and reproductive health at all life stages. It can be used to either plan or avoid pregnancy. Fertility Awareness Methods (FAMs) are highly effective when motivated couples are taught by trained practitioners. These methods are in demand for ecological, medical, cultural, religious and moral reasons. The ability to control fertility naturally is a lifestyle choice. The Complete Guide to Fertility Awareness provides the science and methodology suitable for health professionals and a general audience. It covers reproductive physiology and the fertility indicators: temperature, cervical secretions and cycle length calculations. It explores ways to optimise conception and to manage conception delays. Case studies and self-assessment exercises are included throughout. The book addresses the scientific credibility of new technologies including fertility apps, home test kits, monitors and devices. The Complete Guide to Fertility Awareness offers: evidence-based information for general practitioners, practice nurses, school nurses, midwives, sexual health doctors and nurses a unique perspective on subfertility for gynaecologists and fertility nurses an authoritative source of reference for medical, nursing and midwifery students a straightforward and practical reference for new and experienced FAM users the core text for the FertilityUK Advanced Skills Course in Fertility Awareness

Elementary And Intermediate Algebra

Author : Marvin L. Bittinger
ISBN : 9780134508146
Genre : Mathematics
File Size : 53. 18 MB
Format : PDF, Mobi
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For courses in Beginning & Intermediate Algebra. Understanding and Applying Mathematical Concepts The goal of the Bittinger Concepts and Applications Series is to help today’s student learn and retain mathematical concepts. This proven program prepares students for the transition from skills-oriented elementary algebra courses to more concept-oriented college-level mathematics courses. This requires the development of critical-thinking skills: to reason mathematically, to communicate mathematically, and to identify and solve mathematical problems. The new editions support students with a tightly integrated MyLab™ Math course; a strong focus on problem-solving, applications, and concepts, and the robust MyMathGuide workbook and objective-based video program. In addition, new material—developed as a result of the authors’ experience in the classroom, as well as from insights from faculty and students—includes more systematic review and preparation for practice, as well as stronger focus on real-world applications. Also available with MyLab Math. MyLab™ Math is an online homework, tutorial, and assessment program designed to work with this text to engage students and improve results. Within its structured environment, students practice what they learn, test their understanding, and pursue a personalized study plan that helps them absorb course material and understand difficult concepts. Note: You are purchasing a standalone product; MyLab™ does not come packaged with this content. Students, if interested in purchasing this title with MyLab, ask your instructor for the correct package ISBN and Course ID. Instructors, contact your Pearson representative for more information. If you would like to purchase both the physical text and MyLab, search for: 0134772342 / 9780134772349 Elementary & Intermediate Algebra: Concepts & Applications Plus MyLab Math -- Title-Specific Access Card Package, 7/e Package consists of: 013446270X / 9780134462707 Elementary and Intermediate Algebra: Concepts & Applications 0134762614 / 9780134762616 MyLab Math with Pearson eText -- Standalone Access Card -- for Elementary and Intermediate Algebra: Concepts & Applications

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