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Author: Ben Greenstein
Publisher:
ISBN: 9780857110169
Category : Medical
Languages : en
Pages : 153
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Book Description
An introduction to the treatment of disease using biological medicines derived from living plant and animal tissues.
Author: Ben Greenstein
Publisher:
ISBN: 9780857110169
Category : Medical
Languages : en
Pages : 153
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Book Description
An introduction to the treatment of disease using biological medicines derived from living plant and animal tissues.
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.
Author: Parke, Davis & Company
Publisher:
ISBN:
Category : Antitoxins
Languages : en
Pages : 250
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Book Description
Author: Rodney J. Y. Ho
Publisher: John Wiley & Sons
ISBN: 0471450278
Category : Science
Languages : en
Pages : 576
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Book Description
Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies.
Author: Xiaohui (Sophia) Xu
Publisher: John Wiley & Sons
ISBN: 1119523214
Category : Science
Languages : en
Pages : 404
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Book Description
Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
Author: G. Dickson
Publisher: Springer Science & Business Media
ISBN: 9401105472
Category : Science
Languages : en
Pages : 418
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Book Description
advanced metastatic disease of solid tumors, dictates that each tumor mass, indeed each individual metastasis, will have a unique antigen and cytokine environment and hence unique response to immune modu lation. A differential response to immunotherapy is thus inevitable. 4. Many of the human trials described are not randomized and report survival or response against historical controls. Most tumors described are immunogenic human tumors: renal cell cancer and melanoma are most common. In order to avoid the well-described inter-patient vari ation and rare incidence of spontaneous response among patient samples as well as selection bias and changes in practice over time, randomized trials are required. 5. Immunological treatment is unlike conventional chemotherapy in its endpoint. Most chemotherapeutic regimes require a complete response or a good partial response for cure or good palliation. There are now many cases where immunotherapy has provided long-term palliation without massive tumor reduction. Immunity may be stimulated to a degree which holds tumorigenicity in check and most importantly, pro vides good palliation for the patient in a manner that differs essentially from chemotherapy.
Author: Xiaohui (Sophia) Xu
Publisher: John Wiley & Sons
ISBN: 1119523281
Category : Science
Languages : en
Pages : 404
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Book Description
Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.
Author: Albrecht Eichhorn
Publisher:
ISBN:
Category : Therapeutics
Languages : en
Pages : 84
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Book Description
Author: Bruce Kirkham
Publisher: OUP Oxford
ISBN: 0191548979
Category : Medical
Languages : en
Pages : 176
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Book Description
Drugs produced by molecular biological techniques, called the 'biologics', differ from the usual chemical medications. Their optimum use, and the detection and managemenet of adverse events, pose a significant challenge to the clinician. Licences for new biologics continue to be granted for the likes of rituximab, abatacept and certocizumals pegol. Intensive research is also defining new areas in which these drugs will be used in the future, increasing the number of practitioners using biologics. As the use of these drugs increases around the world, so the level of information needed by primary care practitioners and specialist prescribers needs to be expanded The Handbook of Biological Therapy provides the practising clinician with a practica guide to the use of Tumour Necrosis Factor Blocking Therapy (TNF-blockers), and important new class of biologic therapy for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. It is a comprehensive distillation of the authors' clinical experience with these drugs, combined with data from diverse databases offering practical advice on their uses, specific indications, supporting clinical trial data and safety issues, with the aim of making the use of these drugs easier for the busy clinician. All of the authors have been involved from the beginnings of the clinical trial programmes with these drugs and continue to use them in daily practice.
Author: Dale L. Oxender
Publisher: Springer Science & Business Media
ISBN: 3642599907
Category : Medical
Languages : en
Pages : 261
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Book Description
While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.
