Bioanalytical Aspects in Biological Therapeutics
Sold by Books Puddle, New York, NY, U.S.A.
AbeBooks Seller since 22 November 2018
New - Hardcover
Condition: New
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Quantity: 3 available
Add to basketSold by Books Puddle, New York, NY, U.S.A.
AbeBooks Seller since 22 November 2018
Condition: New
Quantity: 3 available
Add to basketDeepen 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:
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.
Xiaohui Xu, PhD, is Director at Daiichi-Sankyo Inc. She is actively serving in the American Association of Pharmaceutical Scientists (AAPS) PK Assay Group and IQ Consortium Metabolite Working Group. She has extensive experiences in regulated bioanalytical field including global submissions, covering small molecules, biologics and new modalities. She has extensive publications and 2 book chapters. She received her Doctorate in Pharmaceutical Analysis from College of Pharmacy, the University of Georgia.
Weifeng Xu, PhD, is Director at Merck & Co., Inc. He is an active member and leader in the AAPS and the European Bioanalysis Forum’s (EBF) immunogenicity community and has published multiple papers on immunogenicity assay development and validation. He is also co-leading the IQ Consortium Bioanalytical Considerations and Challenges for Cell Therapies subgroup. More recently Weifeng also became Bioanalytic lead to multiple vaccine projects within Merck including COVID-19 and pneumococcal to oversee all clinical immunogenicity assays.
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