Safety of Biologics Therapy

Safety of Biologics Therapy

Author: Brian A. Baldo

Publisher: Springer

Published: 2016-08-12

Total Pages: 610

ISBN-13: 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.


Book Synopsis Safety of Biologics Therapy by : Brian A. Baldo

Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Published: 2012-10-13

Total Pages: 432

ISBN-13: 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.


Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Adverse Reactions to Biologics

Adverse Reactions to Biologics

Author: L. Puig

Publisher: Karger Medical and Scientific Publishers

Published: 2017-11-07

Total Pages: 120

ISBN-13: 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.


Book Synopsis Adverse Reactions to Biologics by : L. Puig

Download or read book Adverse Reactions to Biologics written by L. Puig and published by Karger Medical and Scientific Publishers. This book was released on 2017-11-07 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-04-03

Total Pages: 442

ISBN-13: 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.


Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Treatment of Inflammatory Bowel Disease with Biologics

Treatment of Inflammatory Bowel Disease with Biologics

Author: Adam S. Cheifetz

Publisher: Springer

Published: 2017-11-22

Total Pages: 0

ISBN-13: 9783319602752

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This book is a concise yet comprehensive overview of the use of biologics for the treatment of Crohn’s disease and ulcerative colitis. The volume details how best to utilize these medications in order to optimize their efficacy and safety, as well as how to understand, recognize, and treat complications that may arise from using biologics to treat IBD. The text also focuses on new data, novel biologics, and biosimilars of this rapidly expanding field. Written by experts in the field, Treatment of Inflammatory Bowel Disease with Biologics is a valuable resource for gastroenterologists, allied health professionals, fellows, and trainees who treat patients with inflammatory bowel disease.


Book Synopsis Treatment of Inflammatory Bowel Disease with Biologics by : Adam S. Cheifetz

Download or read book Treatment of Inflammatory Bowel Disease with Biologics written by Adam S. Cheifetz and published by Springer. This book was released on 2017-11-22 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a concise yet comprehensive overview of the use of biologics for the treatment of Crohn’s disease and ulcerative colitis. The volume details how best to utilize these medications in order to optimize their efficacy and safety, as well as how to understand, recognize, and treat complications that may arise from using biologics to treat IBD. The text also focuses on new data, novel biologics, and biosimilars of this rapidly expanding field. Written by experts in the field, Treatment of Inflammatory Bowel Disease with Biologics is a valuable resource for gastroenterologists, allied health professionals, fellows, and trainees who treat patients with inflammatory bowel disease.


Biologic Therapy for Psoriasis

Biologic Therapy for Psoriasis

Author: Nicholas Brownstone

Publisher: Springer Nature

Published: 2022-02-17

Total Pages: 153

ISBN-13: 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.


Book Synopsis Biologic Therapy for Psoriasis by : Nicholas Brownstone

Download or read book Biologic Therapy for Psoriasis written by Nicholas Brownstone and published by Springer Nature. This book was released on 2022-02-17 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Biologics in General Medicine

Biologics in General Medicine

Author: W.-H. Boehncke

Publisher: Springer Science & Business Media

Published: 2007-05-08

Total Pages: 202

ISBN-13: 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.


Book Synopsis Biologics in General Medicine by : W.-H. Boehncke

Download or read book Biologics in General Medicine written by W.-H. Boehncke and published by Springer Science & Business Media. This book was released on 2007-05-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Pharmacoepidemiology

Pharmacoepidemiology

Author: Brian L. Strom

Publisher: John Wiley & Sons

Published: 2019-12-16

Total Pages: 1220

ISBN-13: 1119413419

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This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.


Book Synopsis Pharmacoepidemiology by : Brian L. Strom

Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.


Severe Asthma

Severe Asthma

Author: Kian Fan Chung

Publisher: European Respiratory Society

Published: 2019-06-01

Total Pages: 360

ISBN-13: 1849841047

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Severe asthma is a form of asthma that responds poorly to currently available medication, and its patients represent those with greatest unmet needs. In the last 10 years, substantial progress has been made in terms of understanding some of the mechanisms that drive severe asthma; there have also been concomitant advances in the recognition of specific molecular phenotypes. This ERS Monograph covers all aspects of severe asthma – epidemiology, diagnosis, mechanisms, treatment and management – but has a particular focus on recent understanding of mechanistic heterogeneity based on an analytic approach using various ‘omics platforms applied to clinically well-defined asthma cohorts. How these advances have led to improved management targets is also emphasised. This book brings together the clinical and scientific expertise of those from around the world who are collaborating to solve the problem of severe asthma.


Book Synopsis Severe Asthma by : Kian Fan Chung

Download or read book Severe Asthma written by Kian Fan Chung and published by European Respiratory Society. This book was released on 2019-06-01 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Severe asthma is a form of asthma that responds poorly to currently available medication, and its patients represent those with greatest unmet needs. In the last 10 years, substantial progress has been made in terms of understanding some of the mechanisms that drive severe asthma; there have also been concomitant advances in the recognition of specific molecular phenotypes. This ERS Monograph covers all aspects of severe asthma – epidemiology, diagnosis, mechanisms, treatment and management – but has a particular focus on recent understanding of mechanistic heterogeneity based on an analytic approach using various ‘omics platforms applied to clinically well-defined asthma cohorts. How these advances have led to improved management targets is also emphasised. This book brings together the clinical and scientific expertise of those from around the world who are collaborating to solve the problem of severe asthma.


Biologics in Inflammatory Bowel Disease

Biologics in Inflammatory Bowel Disease

Author: Scott Plevy Associate Professor of Medicine Division of Gastroenterology

Publisher: Oxford University Press, USA

Published: 2010

Total Pages: 64

ISBN-13: 0199749183

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SERIES OVERVIEW: The Oxford American Pocket Notes are a series of ultra-concise, small-format books for healthcare professionals on topics related to the diagnosis, treatment and management of various medical conditions. Each title typically features an outline of key points, guidelines and tools such as patient assessments and treatment algorithms, for a specific area of medical diagnosis and/or management. Highly practical in format, content and style, the Pocket Notes serve as a quick, easily accessible point-of-care reference for busy practitioners. In effect, they are miniature versions of the Oxford American Medical Library and Oxford American Handbooks in Medicine, capturing the key essentials needed for appropriate assessment and treatment. Inflammatory bowel disease (IBD) is a gastrointestinal condition which causes inflammation of the lining of the digestive tract. This disease affects an estimated one million Americans, usually in the forms of ulcerative colitis (UC) and Crohn's disease (CD). These two diseases have similar symptoms and are often confused for one another. Crohn's disease can occur anywhere in the digestive tract, often spreading deep into the layers of affected tissues, but ulcerative colitis usually affects only the innermost lining (mucosa) of the large intestine and rectum. IBD patients suffer from severe diarrhea and abdominal pain, and may experience other complications, such as arthritis and kidney stones, that affect the body beyond the intestinal tract. The Oxford American Pocket Notes: Biologics in Inflammatory Bowel Disease is a practical guide to the safe administration of biological agents to treat inflammatory gastrointestinal illnesses. This ultra-concise and practical volume focuses on tumor necrosis factor (TNF) blocking therapy (TNF blocker), an important new class of biologic therapy indicated for the treatment of several rheumatic and other auto-immune disorders, including Crohn's disease and ulcerative colitis. This uniquely compact and affordable book features evidence-based discussion and guidelines on the mechanism of action, dosing, administration and safety considerations for the biologic agents approved to treat CD and UC, thus providing practicing physicians with easily accessible tools and insights on the use of these drugs in a daily practice setting. Culled from the pages of Handbook of Biological Therapy, this portable guide is a valuable resource for gastroenterologists, primary care physicians and other healthcare providers involved in the management of these chronic but treatable diseases.


Book Synopsis Biologics in Inflammatory Bowel Disease by : Scott Plevy Associate Professor of Medicine Division of Gastroenterology

Download or read book Biologics in Inflammatory Bowel Disease written by Scott Plevy Associate Professor of Medicine Division of Gastroenterology and published by Oxford University Press, USA. This book was released on 2010 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: SERIES OVERVIEW: The Oxford American Pocket Notes are a series of ultra-concise, small-format books for healthcare professionals on topics related to the diagnosis, treatment and management of various medical conditions. Each title typically features an outline of key points, guidelines and tools such as patient assessments and treatment algorithms, for a specific area of medical diagnosis and/or management. Highly practical in format, content and style, the Pocket Notes serve as a quick, easily accessible point-of-care reference for busy practitioners. In effect, they are miniature versions of the Oxford American Medical Library and Oxford American Handbooks in Medicine, capturing the key essentials needed for appropriate assessment and treatment. Inflammatory bowel disease (IBD) is a gastrointestinal condition which causes inflammation of the lining of the digestive tract. This disease affects an estimated one million Americans, usually in the forms of ulcerative colitis (UC) and Crohn's disease (CD). These two diseases have similar symptoms and are often confused for one another. Crohn's disease can occur anywhere in the digestive tract, often spreading deep into the layers of affected tissues, but ulcerative colitis usually affects only the innermost lining (mucosa) of the large intestine and rectum. IBD patients suffer from severe diarrhea and abdominal pain, and may experience other complications, such as arthritis and kidney stones, that affect the body beyond the intestinal tract. The Oxford American Pocket Notes: Biologics in Inflammatory Bowel Disease is a practical guide to the safe administration of biological agents to treat inflammatory gastrointestinal illnesses. This ultra-concise and practical volume focuses on tumor necrosis factor (TNF) blocking therapy (TNF blocker), an important new class of biologic therapy indicated for the treatment of several rheumatic and other auto-immune disorders, including Crohn's disease and ulcerative colitis. This uniquely compact and affordable book features evidence-based discussion and guidelines on the mechanism of action, dosing, administration and safety considerations for the biologic agents approved to treat CD and UC, thus providing practicing physicians with easily accessible tools and insights on the use of these drugs in a daily practice setting. Culled from the pages of Handbook of Biological Therapy, this portable guide is a valuable resource for gastroenterologists, primary care physicians and other healthcare providers involved in the management of these chronic but treatable diseases.