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Immunogenicity of Biopharmaceuticals

2008-02-06 Medical
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Release : 2008-02-06
Genre : Medical
Kind : eBook
Book Rating : 410/5 ( reviews)

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Book Synopsis Immunogenicity of Biopharmaceuticals by : Marco Weert

Download or read book Immunogenicity of Biopharmaceuticals written by Marco Weert. This book was released on 2008-02-06. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Immune Aspects of Biopharmaceuticals and Nanomedicines

2019-01-15 Medical
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Release : 2019-01-15
Genre : Medical
Kind : eBook
Book Rating : 780/5 ( reviews)

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Book Synopsis Immune Aspects of Biopharmaceuticals and Nanomedicines by : Raj Bawa

Download or read book Immune Aspects of Biopharmaceuticals and Nanomedicines written by Raj Bawa. This book was released on 2019-01-15. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Detection and Quantification of Antibodies to Biopharmaceuticals

2011-07-12 Medical
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Release : 2011-07-12
Genre : Medical
Kind : eBook
Book Rating : 676/5 ( reviews)

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Book Synopsis Detection and Quantification of Antibodies to Biopharmaceuticals by : Michael G. Tovey

Download or read book Detection and Quantification of Antibodies to Biopharmaceuticals written by Michael G. Tovey. This book was released on 2011-07-12. Available in PDF, EPUB and Kindle. Book excerpt: The definitive book on the neutralization of recombinant biopharmaceuticals Recombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects. The first and only book to cover neutralization in connection with biopharmaceuticals and the measurement and application of neutralizing antibodies in modern medicine at any real length, Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations offers a comprehensive and in-depth look at all the principal aspects of the detection and quantification of antibodies that are essential to understanding and responding to the challenges they present. Bringing together a large-scale review of neutralization and biopharmaceuticals and the ability to measure, detect, and apply antibodies to modern science and medicine with international regulatory perspectives, the expectations of regulatory authorities, and the strengths and weaknesses of various assays, the book describes several novel ideas for detecting ADAs. Designed to serve as a resource for biopharmaceutical drug development, the book provides biotechnology companies and pharmaceutical drug development specialists, as well as non-experts, with key insights into the design, optimization, and qualification of assays, the establishment of sampling strategies, the choice of appropriate assay end-points, and data analysis for the detection and quantification of neutralizing antibodies.

Statistical Methods for Immunogenicity Assessment

2015-07-17 Mathematics
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Release : 2015-07-17
Genre : Mathematics
Kind : eBook
Book Rating : 357/5 ( reviews)

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Book Synopsis Statistical Methods for Immunogenicity Assessment by : Harry Yang

Download or read book Statistical Methods for Immunogenicity Assessment written by Harry Yang. This book was released on 2015-07-17. Available in PDF, EPUB and Kindle. Book excerpt: 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

Clinical Concerns of Immunogenicity Produced by Biopharmaceuticals

2010-09
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Release : 2010-09
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Kind : eBook
Book Rating : 008/5 ( reviews)

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Book Synopsis Clinical Concerns of Immunogenicity Produced by Biopharmaceuticals by : Tamilvanan Shunmugaperumal

Download or read book Clinical Concerns of Immunogenicity Produced by Biopharmaceuticals written by Tamilvanan Shunmugaperumal. This book was released on 2010-09. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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