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Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani D, Marsden R, Gunsior M, Hay LS, Ward B, Cowan KJ, Azadeh M, Barker B, Cao L, Closson KR, Coble K, Dholakiya SL, Dusseault J, Hays A, Herl C, Hodsdon ME, Irvin SC, Kirshner S, Kolaitis G, Kulagina N, Kumar S, Lai CH, Lipari F, Liu S, Merdek KD, Moldovan IR, Mozaffari R, Pan L, Place C, Snoeck V, Manning MS, Stocker D, Tary-Lehmann M, Turner A, Vainshtein I, Verthelyi D, Williams WT, Yan H, Yan W, Yang L, Yang L, Zemo J, Zhong ZD. Jani D, et al. Among authors: kumar s. AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6. AAPS J. 2022. PMID: 36307592
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.
Gokemeijer J, Wen Y, Jawa V, Mitra-Kaushik S, Chung S, Goggins A, Kumar S, Lamberth K, Liao K, Lill J, Phung Q, Walsh R, Roberts BJ, Swanson M, Singh I, Tourdot S, Kroenke MA, Rup B, Goletz TJ, Gupta S, Malherbe L, Pattijn S. Gokemeijer J, et al. Among authors: kumar s. AAPS J. 2023 Jun 2;25(4):55. doi: 10.1208/s12248-023-00820-7. AAPS J. 2023. PMID: 37266912
Risk-Based Pharmacokinetic and Drug-Drug Interaction Characterization of Antibody-Drug Conjugates in Oncology Clinical Development: An International Consortium for Innovation and Quality in Pharmaceutical Development Perspective.
Li C, Menon R, Walles M, Singh R, Upreti VV, Brackman D, Lee AJ, Endres CJ, Kumar S, Zhang D, Barletta F, Suri A, Hainzl D, Liao KH, Lalovic B, Beaumont M, Zuo P, Mayer AP, Wei D. Li C, et al. Among authors: kumar s. Clin Pharmacol Ther. 2022 Oct;112(4):754-769. doi: 10.1002/cpt.2448. Epub 2021 Nov 23. Clin Pharmacol Ther. 2022. PMID: 34657311
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. Hersey S, et al. Among authors: kumar s. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
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