02767nam 2200433 450 991083067980332120221228181739.01-119-52324-91-119-52323-0(MiAaPQ)EBC7031379(Au-PeEL)EBL7031379(CKB)24169243800041(OCoLC)1334890260(EXLCZ)992416924380004120221228d2022 uy 0engurcnu||||||||txtrdacontentcrdamediacrrdacarrierBioanalytical aspects in biological therapeutics /edited by Xiaohui Xu, Weifeng XuHoboken, New Jersey :John Wiley & Sons, Inc.,[2022]©20221 online resource (394 pages)Includes index.Print version: Xu, Xiaohui (Sophia) Bioanalytical Aspects in Biological Therapeutics Newark : John Wiley & Sons, Incorporated,c2022 9781119523215 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.Biological productsTherapeutic useBiological productsTherapeutic use.615.19Xu Weifeng(Director at Merck),Xu XiaohuiPh.D.,MiAaPQMiAaPQMiAaPQBOOK9910830679803321Bioanalytical aspects in biological therapeutics3929125UNINA