LEADER 02767nam 2200433 450 001 9910830679803321 005 20221228181739.0 010 $a1-119-52324-9 010 $a1-119-52323-0 035 $a(MiAaPQ)EBC7031379 035 $a(Au-PeEL)EBL7031379 035 $a(CKB)24169243800041 035 $a(OCoLC)1334890260 035 $a(EXLCZ)9924169243800041 100 $a20221228d2022 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aBioanalytical aspects in biological therapeutics /$fedited by Xiaohui Xu, Weifeng Xu 210 1$aHoboken, New Jersey :$cJohn Wiley & Sons, Inc.,$d[2022] 210 4$dİ2022 215 $a1 online resource (394 pages) 300 $aIncludes index. 311 08$aPrint version: Xu, Xiaohui (Sophia) Bioanalytical Aspects in Biological Therapeutics Newark : John Wiley & Sons, Incorporated,c2022 9781119523215 327 $aOverview 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 Ferna?ndez-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. 606 $aBiological products$xTherapeutic use 615 0$aBiological products$xTherapeutic use. 676 $a615.19 702 $aXu$b Weifeng$c(Director at Merck), 702 $aXu$b Xiaohui$cPh.D., 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830679803321 996 $aBioanalytical aspects in biological therapeutics$93929125 997 $aUNINA