Clinical Concerns of Immunogenicity Produced by Biopharmaceuticals PDF Download
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Author: Tamilvanan Shunmugaperumal
Publisher: LAP Lambert Academic Publishing
ISBN: 9783843356008
Category :
Languages : en
Pages : 92
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Book Description
Following the administration of biopharmaceuticals into human body, the formation of antidrug or neutralizing antibodies and other general immune system effects (including allergy, anaphylaxis, or serum sickness) are of clinical concerns regarding therapeutic efficacy and patient safety. For example, drug-induced neutralizing antibodies to erythropoietin (EPO) result in pure red cell aplasia, whereas drug-induced/acquired anti-factor VIII antibodies worsen the pathology associated with hemophilia. The possible mechanism, prediction and reduction of immunogenicity produced by biopharmaceuticals are overviewed. This book encompasses the clinical concerns of immunogenicity produced by various biopharmaceuticals such as growth hormone, insulins, granulocyte-macrophage colony-stimulating factor, interferons, megakaryocyte differentiation and growth factor, EPO, factor VIII, factor IX, acid alpha-glucosidase and glatiramer acetate including their biosimilar versions wherever possible. With this coverage of very interesting informations, this book is an essential reference for researchers in pharmaceutical industry who develop biopharmaceutical products.
Author: Tamilvanan Shunmugaperumal
Publisher: LAP Lambert Academic Publishing
ISBN: 9783843356008
Category :
Languages : en
Pages : 92
Get Book Here
Book Description
Following the administration of biopharmaceuticals into human body, the formation of antidrug or neutralizing antibodies and other general immune system effects (including allergy, anaphylaxis, or serum sickness) are of clinical concerns regarding therapeutic efficacy and patient safety. For example, drug-induced neutralizing antibodies to erythropoietin (EPO) result in pure red cell aplasia, whereas drug-induced/acquired anti-factor VIII antibodies worsen the pathology associated with hemophilia. The possible mechanism, prediction and reduction of immunogenicity produced by biopharmaceuticals are overviewed. This book encompasses the clinical concerns of immunogenicity produced by various biopharmaceuticals such as growth hormone, insulins, granulocyte-macrophage colony-stimulating factor, interferons, megakaryocyte differentiation and growth factor, EPO, factor VIII, factor IX, acid alpha-glucosidase and glatiramer acetate including their biosimilar versions wherever possible. With this coverage of very interesting informations, this book is an essential reference for researchers in pharmaceutical industry who develop biopharmaceutical products.
Author: Marco Weert
Publisher: Springer Science & Business Media
ISBN: 0387758410
Category : Medical
Languages : en
Pages : 269
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Book Description
Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.
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.
Author: Harry Yang
Publisher: CRC Press
ISBN: 1498700357
Category : Mathematics
Languages : en
Pages : 259
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Book Description
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra
Author:
Publisher: ScholarlyEditions
ISBN: 1464963428
Category : Medical
Languages : en
Pages : 4229
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Book Description
Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Author: Raj Bawa
Publisher: CRC Press
ISBN: 1351399780
Category : Medical
Languages : en
Pages : 44
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Book Description
The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.
Author: Amy Rosenberg
Publisher: Frontiers Media SA
ISBN: 2889662888
Category : Medical
Languages : en
Pages : 328
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Book Description
Topic Editor Susan Richards is an employee of Sanofi and owns stock in the corporation. Topic Editor Bernard Maillere declares economic support from pharmaceutical companies (Novartis, Sanofi, and UCB) in the frame of collaborations aiming to evaluate the recognition by human T cells of therapeutic proteins and antibodies.
Author: Raj Bawa
Publisher: CRC Press
ISBN: 1351399772
Category : Medical
Languages : en
Pages : 602
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Book Description
The enormous advances in the immunologic aspects of biotherapeutics and nanomedicines in the past two decades has necessitated an authoritative and comprehensive reference source that can be relied upon by immunologists, biomedical researchers, clinicians, pharmaceutical companies, regulators, venture capitalists, and policy makers alike. This text provides a thorough understanding of immunology, therapeutic potential, clinical applications, adverse reactions, and approaches to overcoming immunotoxicity of biotherapeutics and nanomedicines. It also tackles critical, yet often overlooked topics such as immune aspects of nano-bio interactions, current FDA regulatory guidances, complement activation-related pseudoallergy (CARPA), advances in nanovaccines, and immunogenicity testing of protein therapeutics.
Author: Werner J. Pichler
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805582692
Category : Medical
Languages : en
Pages : 440
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Book Description
Approaches the phenomenon of drug hypersensitivity in a comprehensive manner. Besides epidemiological aspects, it addresses the immunological mechanisms underlying these complicated reactions which go far beyond the IgE-mediated drug allergies also considered in this book. The book also covers clinical manifestations and new diagnostic methods, and introduces some recetly established animal models. Many topics are treated from multiple perspectives, and the 33 chapters are thoroughly cross-referenced.
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 149874348X
Category : Medical
Languages : en
Pages : 599
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Book Description
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.
