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[null,"1.","Record Nr.",null,"UNINA9910830679803321"]
[null,null,"Titolo",null,"Bioanalytical aspects in biological therapeutics / / edited by Xiaohui Xu, Weifeng Xu"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, New Jersey : , : John Wiley & Sons, Inc., , [2022]"]
[{"$nulls":4},"©2022"]
[null,null,"ISBN",null,"1-119-52324-9"]
[{"$nulls":4},"1-119-52323-0"]
[null,null,"Descrizione fisica",null,"1 online resource (394 pages)"]
[null,null,"Disciplina",null,"615.19"]
[null,null,"Soggetti",null,"Biological products - Therapeutic use"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Includes index."]
[null,null,"Nota di contenuto",null,"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."]