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Bioanalytical Aspects in Biological Therapeutics



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Wiley


Paru le : 2022-07-06



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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.
Pages
400 pages
Collection
n.c
Parution
2022-07-06
Marque
Wiley
EAN papier
9781119523215
EAN PDF
9781119523239
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
400
Taille du fichier
7076 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
175,87 €
EAN EPUB
9781119523284
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
400
Taille du fichier
21832 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
175,87 €

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