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Bioanalytical aspects in biological therapeutics / / edited by Xiaohui Xu, Weifeng Xu



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Titolo: Bioanalytical aspects in biological therapeutics / / edited by Xiaohui Xu, Weifeng Xu Visualizza cluster
Pubblicazione: Hoboken, New Jersey : , : John Wiley & Sons, Inc., , [2022]
©2022
Descrizione fisica: 1 online resource (394 pages)
Disciplina: 615.19
Soggetto topico: Biological products - Therapeutic use
Persona (resp. second.): XuWeifeng (Director at Merck)
XuXiaohui, Ph.D.
Note generali: Includes index.
Nota di contenuto: Overview of the development of biotherapeutics and the role of bioanalytical sciences / Robert Dodge -- Basic immunology for bioanalytical testing of biotherapeutics / Kang Chen and Weifeng Xu -- Platform and instrument considerations in bioanalytical testing / Dominic Warrino and Frank Spriggs -- Pharmacokinetic assays / Tong-Yuan Yang and Eric Wakshull -- Recent progress in biomarker bioanalysis and target engagement assessment / Yan G. Ni, Lindsay King, and Carmen Fernández-Metzler -- Immunogenicity risk prediction and assessment for biotherapeutics / Jochem Gokemeijer -- Bioanalytical strategy to support clinical immunogenicity assessment : antidrug antibodies / Ying Wang and Michael Luong -- Bioanalytical scheme for antidrug neutralizing antibody assays / Weifeng Xu, Bonnie Wu and Jim McNally -- Critical reagents in bioanalysis / Yang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek -- Statistical aspects of bioanalytical testing / Arkady M. Gershteyn and Mark Ma -- Bioanalytical aspects in biological therapeutics : biotransformation / Wenying Jian, Cong Wei and Jinping Gan -- New modalities : multidomain therapeutics and gene therapy programs / Kelly Colletti and Mark Ma -- Regulatory aspects for assay development, validation, and sample analysis / Amy Lavelle and Megan Wiberg.
Titolo autorizzato: Bioanalytical aspects in biological therapeutics  Visualizza cluster
ISBN: 1-119-52324-9
1-119-52323-0
Formato: Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione: Inglese
Record Nr.: 9910830679803321
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