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Safety of Biologics Therapy

Safety of Biologics Therapy
Author: Brian A. Baldo
Publisher: Springer
Total Pages: 623
Release: 2016-08-12
Genre: Medical
ISBN: 3319304720

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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.


Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 432
Release: 2012-10-13
Genre: Medical
ISBN: 0309225493

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The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.


Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 442
Release: 2011-04-03
Genre: Medical
ISBN: 0309158060

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.


Adverse Reactions to Biologics

Adverse Reactions to Biologics
Author: L. Puig
Publisher: Karger Medical and Scientific Publishers
Total Pages: 120
Release: 2017-11-07
Genre: Medical
ISBN: 3318061018

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In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field.


Biologics in General Medicine

Biologics in General Medicine
Author: W.-H. Boehncke
Publisher: Springer Science & Business Media
Total Pages: 202
Release: 2007-05-08
Genre: Medical
ISBN: 3540290176

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This is the first book to cover every angle in the clinical application of biologics. Readers will not only find that all of the biologics currently approved for clinical use are delineated in a standardized way, but also the "differential therapy" with biologics in fields including dermatology and neurology is described in detail and summarized in treatment algorithms. Shorter sections on biologic biotechnology as well as safety and regulatory issues complement the more clinically-oriented central chapters.


Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
Author: Iqbal Ramzan
Publisher: John Wiley & Sons
Total Pages: 328
Release: 2021-02-03
Genre: Medical
ISBN: 1119564654

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A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists


Biologic Therapy for Psoriasis

Biologic Therapy for Psoriasis
Author: Nicholas Brownstone
Publisher: Springer Nature
Total Pages: 153
Release: 2022-02-17
Genre: Medical
ISBN: 3030929388

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Biologic therapy is a treatment that strives to modulate a patient's immune system to fight a given disease. In psoriasis, a skin disorder that is partly caused by a dysregulated immune system resulting in well-demarcated red areas of the skin with white scales, biologic therapy has the potential to vastly improve upon patient outcomes by minimizing the symptoms of this disease while maximizing the safety profile of the therapy. This book offers an up-to-date and comprehensive review on biologic therapy for the treatment of psoriasis. With over 10 FDA approved biologic agents for psoriasis (with more in the pipeline), confusion exists among providers regarding which agent is best for a particular patient. Chapters cover all FDA approved psoriasis biologic agents (including pipeline agents) for use in pediatric, adult, and geriatric patients. This book is unique in that it will not only cover cutting edge treatment principles based on the latest research, it will also be one of the most comprehensive reviews of psoriasis biologics in the COVID-19 era. Biologic Therapy for Psoriasis is a must-have resource for board certified dermatologists and rheumatologists, dermatology and rheumatology residents and fellows, dermatology physician assistants, nurse practitioners and medical students. The ultimate goal of this book is to improve patient care by making the busy practicing dermatology provider more adept with these particular therapies.


Moderate to Severe Psoriasis, Fourth Edition

Moderate to Severe Psoriasis, Fourth Edition
Author: John Y. M. Koo
Publisher: CRC Press
Total Pages: 422
Release: 2014-03-18
Genre: Medical
ISBN: 1482215160

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Written by experts in the dermatology field, this new fourth edition of Moderate-to-Severe Psoriasis discusses the current use of biologics and other pharmacologic and phototherapy treatments for moderate-to-severe psoriasis. Illustrated with high quality color figures, this standalone text emphasizes safe and effective treatments for the psoriasis patient that are perfect for the dermatologist in daily practice. New to this edition are chapters on day treatment programs, new agents, erythrodermic and pustular psoriasis, special populations, and pharmacogenetics.


Biologics for the Treatment of Rheumatoid Arthritis

Biologics for the Treatment of Rheumatoid Arthritis
Author: Ronald van Vollenhoven
Publisher: Adis
Total Pages: 0
Release: 2016-01-06
Genre: Medical
ISBN: 9783319131078

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This book provides a comprehensive overview of the available biologic therapies whilst comparing them to standard disease modifying anti-rheumatic drugs, and discusses how best to determine which therapy is most appropriate for an individual patient in the framework of current guidelines. Biologics for the Treatment of Rheumatoid Arthritis is an up-to-date and concise practical guide to the latest therapeutic developments in this field. This book is an invaluable source of topical information for all rheumatologists and health care professionals treating patients with rheumatoid arthritis.


The Handbook of Biological Therapy

The Handbook of Biological Therapy
Author: Bruce Kirkham
Publisher: OUP Oxford
Total Pages: 176
Release: 2008-11-27
Genre: Medical
ISBN: 0191548979

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Drugs produced by molecular biological techniques, called the 'biologics', differ from the usual chemical medications. Their optimum use, and the detection and managemenet of adverse events, pose a significant challenge to the clinician. Licences for new biologics continue to be granted for the likes of rituximab, abatacept and certocizumals pegol. Intensive research is also defining new areas in which these drugs will be used in the future, increasing the number of practitioners using biologics. As the use of these drugs increases around the world, so the level of information needed by primary care practitioners and specialist prescribers needs to be expanded The Handbook of Biological Therapy provides the practising clinician with a practica guide to the use of Tumour Necrosis Factor Blocking Therapy (TNF-blockers), and important new class of biologic therapy for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. It is a comprehensive distillation of the authors' clinical experience with these drugs, combined with data from diverse databases offering practical advice on their uses, specific indications, supporting clinical trial data and safety issues, with the aim of making the use of these drugs easier for the busy clinician. All of the authors have been involved from the beginnings of the clinical trial programmes with these drugs and continue to use them in daily practice.