Bioanalytical Aspects In Biological Therapeutics (EPUB)
Written by Xiaohui (Sophia) Xu
Aspects of Bioanalytics in Biological Therapeutics
Expand your knowledge of how important bioanalysis data are produced.
A group of distinguished biologists, chemists, and immunologists present a comprehensive and useful overview of the vast body of
scientific and technical literature on the bioanalytical analysis of active biotherapeutics in development in Bioanalytical Aspects in
Biological Therapeutics.
The book covers a wide range of important topics in the field, including the overview and basic immunology for testing biological
therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation
assessment for biologics, statistical aspects of bioanalytical
testing, regulatory expectations and more.
It also discusses the challenges and considerations for bioanalytical support.
Professionals in drug development and analysis will gain knowledge about how bioanalysis generates important data and how well
proven techniques and technologies are used in the creation of biologics.
Readers will gain from: Comprehensive coverage of subjects like as PK, immunogenicity, neutralizing antibody tests and the
significance of reagent quality control.
a comprehensive review of basic immunology for bioanalytical testing of biological therapies, as well as the creation of biotherapeutics
and the function of bioanalytical tests thorough investigations of platform and instrument issues in pharmacokinetics tests,
bioanalytical testing and biomarker analysis utilizing LC-MS, LBA and other technologies Discussions of bioanalytical systems for
anti-drug neutralizing antibody assays, preclinical and clinical anti-drug antibody assays and immunogenicity prediction in practice
thorough analyses of important bioanalytic reagents Regulations governing the creation, validation and testing of bioanalytical
methods and samples Bioanalytical Aspects in Biological Therapeutics is ideal for pharmaceutical scientists working in industry.
It will also become a valuable addition to the libraries of pharmaceutical regulators, professionals in the pharmaceutical industry and
graduate students studying bioanalytical assays for biological therapeutics.
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