Adverse Reactions to Biologics

Adverse Reactions to Biologics PDF Author: L. Puig
Publisher: Karger Medical and Scientific Publishers
ISBN: 3318061018
Category : Medical
Languages : en
Pages : 120

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Book Description
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.

Adverse Reactions to Biologics

Adverse Reactions to Biologics PDF Author: L. Puig
Publisher: Karger Medical and Scientific Publishers
ISBN: 3318061018
Category : Medical
Languages : en
Pages : 120

Get Book

Book Description
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.

Safety of Biologics Therapy

Safety of Biologics Therapy PDF Author: Brian A. Baldo
Publisher: Springer
ISBN: 3319304720
Category : Medical
Languages : en
Pages : 610

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Book Description
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 PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432

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Book Description
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.

Severe Asthma

Severe Asthma PDF Author: Kian Fan Chung
Publisher: European Respiratory Society
ISBN: 1849841047
Category : Medical
Languages : en
Pages : 360

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Book Description
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.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
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.

Allergic Reactions to Drugs

Allergic Reactions to Drugs PDF Author: Alain L. de Weck
Publisher: Springer Science & Business Media
ISBN: 3642690882
Category : Medical
Languages : en
Pages : 771

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Book Description
According to most studies, allergic reactions represent 35%-50% of all untoward reactions to drugs, yet the pharmacological literature concerning the clinical aspects, diagnosis, and pathophysiological mechanisms of drug allergy is markedly less extensive than reports dealing with the toxicological or pharmacological effects of drugs. The main reasons for this state of affairs may be on the one hand that until a few years ago the pathophysiological mechanisms of the various types of allergic reactions were not well understood, and on the other hand that objective diagnosis of a drug allergy is still fraught with serious difficulties. Drug allergy is still an unpopular topic for most allergologists and pharmacologists; this is reflected by the fact that despite their frequency, allergic reactions to drugs still occupy a relatively small proportion of space in most pharmacology handbooks and in classical books devoted to the side effects of drugs. There has recently been considerable progress in research into the immunologi cal and pathophysiological events occurring in allergic reactions, and on that basis investigations of various drug allergies have also yield~d new objective findings. Consequently, it was natural to attempt a review of the most frequent and important drug allergies in the form of a handbook. We originally intended to present a comprehensive review of all drug allergies, but the realization of this goal soon became more difficult than we had at first imagined.

Biologics in General Medicine

Biologics in General Medicine PDF Author: W.-H. Boehncke
Publisher: Springer Science & Business Media
ISBN: 3540290176
Category : Medical
Languages : en
Pages : 202

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Book Description
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.

Adverse Drug Reactions

Adverse Drug Reactions PDF Author: Jack Uetrecht
Publisher: Springer Science & Business Media
ISBN: 3642006639
Category : Medical
Languages : en
Pages : 552

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Book Description
This book provides the current state of knowledge of basic mechanisms of adverse drug reactions (ADRs). The main focus is on idiosyncratic drug reactions because they are the most difficult to deal with. It starts with a general description of the major targets for ADRs followed by a description of what are presently believed to be mediators and biochemical pathways involved in idiosyncratic drug reactions. There is also a description of several examples of ADRs that serve to illustrate specific aspects of ADR mechanisms. Eventually the book shows that ultimately better methods are needed to predict which drug candidates are likely to cause ADRs and which patients are at increased risk. But at present research seems to be far from this goal.

Handbook of Biologics & Biosimilars in Dermatology

Handbook of Biologics & Biosimilars in Dermatology PDF Author: Manas Chatterjee
Publisher: JP Medical Ltd
ISBN: 9352703642
Category : Medical
Languages : en
Pages : 349

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Book Description
A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters explain their therapeutic use for different skin conditions. The final sections cover related topics such as cost effectiveness and quality of life with biologic therapy, and the book concludes with discussion on future developments and the use of small molecule treatment. Key points Complete guide to use of biologics and biosimilars in treatment of dermatologic disorders Covers many different skin diseases and conditions Discusses related topics such as cost effectiveness and quality of life Covers future development of small molecule therapy

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 396

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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.