Safety of Biologics Therapy

Safety of Biologics Therapy PDF Author: Brian A. Baldo
Publisher: Springer
ISBN: 3319304720
Category : Medical
Languages : en
Pages : 623

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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.

Safety of Biologics Therapy

Safety of Biologics Therapy PDF Author: Brian A. Baldo
Publisher: Springer
ISBN: 3319304720
Category : Medical
Languages : en
Pages : 623

Get Book Here

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.

Treatment of Inflammatory Bowel Disease with Biologics

Treatment of Inflammatory Bowel Disease with Biologics PDF Author: Adam S. Cheifetz
Publisher: Springer
ISBN: 3319602764
Category : Medical
Languages : en
Pages : 337

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Book Description
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.

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.

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters PDF Author: Iqbal Ramzan
Publisher: John Wiley & Sons
ISBN: 1119564654
Category : Medical
Languages : en
Pages : 328

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Book Description
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

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.

Pharmacoepidemiology

Pharmacoepidemiology PDF Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

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Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Moderate to Severe Psoriasis, Fourth Edition

Moderate to Severe Psoriasis, Fourth Edition PDF Author: John Y. M. Koo
Publisher: CRC Press
ISBN: 1482215160
Category : Medical
Languages : en
Pages : 422

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Book Description
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.

Respiratory Disease in Pregnancy

Respiratory Disease in Pregnancy PDF Author: Stephen E. Lapinsky
Publisher: Cambridge University Press
ISBN: 1108168795
Category : Medical
Languages : en
Pages : 261

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Book Description
Respiratory diseases affect a large proportion of the population and can cause complications when associated with pregnancy. Pregnancy induces profound anatomical and functional physiological changes in the mother, and subjects the mother to pregnancy-specific respiratory conditions. Reviewing respiratory conditions both specific and non-specific to pregnancy, the book also addresses related issues such as smoking and mechanical ventilation. Basic concepts for the obstetrician are covered, including patient history, physiology and initial examinations. Topics such as physiological changes during pregnancy and placental gas exchange are discussed for the non-obstetrician. Guidance is practical, covering antenatal and post-partum care, as well as management in the delivery suite. An essential guide to respiratory diseases in pregnancy, this book is indispensable to both obstetricians and non-obstetric physicians managing pregnant patients.

Severe Asthma

Severe Asthma PDF Author: Kian Fan Chung
Publisher: European Respiratory Society
ISBN: 1849841047
Category : Medical
Languages : en
Pages : 365

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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.

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals PDF Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
ISBN: 1118679385
Category : Medical
Languages : en
Pages : 1012

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Book Description
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.