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For: Wang YM, Fang L, Zhou L, Wang J, Ahn HY. A survey of applications of biological products for drug interference of immunogenicity assays. Pharm Res 2012;29:3384-92. [PMID: 22903525 DOI: 10.1007/s11095-012-0833-2] [Cited by in Crossref: 33] [Cited by in F6Publishing: 28] [Article Influence: 3.3] [Reference Citation Analysis]
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5 Dinis-oliveira RJ. Heterogeneous and homogeneous immunoassays for drug analysis. Bioanalysis 2014;6:2877-96. [DOI: 10.4155/bio.14.208] [Cited by in Crossref: 23] [Cited by in F6Publishing: 18] [Article Influence: 2.9] [Reference Citation Analysis]
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10 Chamberlain P. Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations. Bioanalysis 2013;5:561-74. [DOI: 10.4155/bio.13.6] [Cited by in Crossref: 29] [Cited by in F6Publishing: 20] [Article Influence: 3.2] [Reference Citation Analysis]
11 Llinares-tello F, Rosas-gómez de Salazar J, Senabre-gallego JM, Santos-soler G, Santos-ramírez C, Salas-heredia E, Barber-vallés X, Molina-garcía J; AIRE-MB Group. Practical application of acid dissociation in monitoring patients treated with adalimumab. Rheumatol Int 2014;34:1701-8. [DOI: 10.1007/s00296-014-3032-0] [Cited by in Crossref: 15] [Cited by in F6Publishing: 13] [Article Influence: 1.9] [Reference Citation Analysis]
12 Strik AS, Wang YC, Ruff LE, Yashar W, Messmer BT, Mould DR. Individualized Dosing of Therapeutic Monoclonal Antibodies-a Changing Treatment Paradigm? AAPS J 2018;20:99. [PMID: 30187153 DOI: 10.1208/s12248-018-0257-y] [Cited by in Crossref: 14] [Cited by in F6Publishing: 11] [Article Influence: 3.5] [Reference Citation Analysis]
13 Crisino RM, Luo L, Geist B, Zoghbi J, Spriggs F. Matrix effect in ligand-binding assay: the importance of evaluating emerging technologies. Bioanalysis 2014;6:1033-6. [DOI: 10.4155/bio.14.39] [Cited by in Crossref: 8] [Cited by in F6Publishing: 7] [Article Influence: 1.0] [Reference Citation Analysis]
14 Wang YM, Wang J, Hon YY, Zhou L, Fang L, Ahn HY. Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective. AAPS J 2016;18:395-403. [PMID: 26721560 DOI: 10.1208/s12248-015-9857-y] [Cited by in Crossref: 51] [Cited by in F6Publishing: 43] [Article Influence: 7.3] [Reference Citation Analysis]
15 Bloem K, Hernández-Breijo B, Martínez-Feito A, Rispens T. Immunogenicity of Therapeutic Antibodies: Monitoring Antidrug Antibodies in a Clinical Context. Ther Drug Monit 2017;39:327-32. [PMID: 28463887 DOI: 10.1097/FTD.0000000000000404] [Cited by in Crossref: 28] [Cited by in F6Publishing: 14] [Article Influence: 7.0] [Reference Citation Analysis]
16 Chen LZ, Roos D, Philip E. Development of Immunocapture-LC/MS Assay for Simultaneous ADA Isotyping and Semiquantitation. J Immunol Res 2016;2016:7682472. [PMID: 27034966 DOI: 10.1155/2016/7682472] [Cited by in Crossref: 19] [Cited by in F6Publishing: 14] [Article Influence: 3.2] [Reference Citation Analysis]
17 Vaisman-Mentesh A, Gutierrez-Gonzalez M, DeKosky BJ, Wine Y. The Molecular Mechanisms That Underlie the Immune Biology of Anti-drug Antibody Formation Following Treatment With Monoclonal Antibodies. Front Immunol 2020;11:1951. [PMID: 33013848 DOI: 10.3389/fimmu.2020.01951] [Cited by in Crossref: 14] [Cited by in F6Publishing: 11] [Article Influence: 7.0] [Reference Citation Analysis]
18 van Schouwenburg PA, Rispens T, Wolbink GJ. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2013;9:164-172. [PMID: 23399692 DOI: 10.1038/nrrheum.2013.4] [Cited by in Crossref: 268] [Cited by in F6Publishing: 245] [Article Influence: 29.8] [Reference Citation Analysis]
19 Passey C, Suryawanshi S, Sanghavi K, Gupta M. Reporting, Visualization, and Modeling of Immunogenicity Data to Assess Its Impact on Pharmacokinetics, Efficacy, and Safety of Monoclonal Antibodies. AAPS J 2018;20:35. [PMID: 29484520 DOI: 10.1208/s12248-018-0194-9] [Cited by in Crossref: 7] [Cited by in F6Publishing: 7] [Article Influence: 1.8] [Reference Citation Analysis]
20 Kurki P. Compatibility of immunogenicity guidance by the EMA and the US FDA. Bioanalysis 2019;11:1619-29. [DOI: 10.4155/bio-2018-0243] [Cited by in Crossref: 5] [Cited by in F6Publishing: 5] [Article Influence: 1.7] [Reference Citation Analysis]
21 van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer 2019;7:212. [PMID: 31395089 DOI: 10.1186/s40425-019-0663-4] [Cited by in Crossref: 10] [Cited by in F6Publishing: 11] [Article Influence: 3.3] [Reference Citation Analysis]
22 Wang YC, Jawa V, Ma M. Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis. Bioanalysis 2014;6:79-87. [DOI: 10.4155/bio.13.302] [Cited by in Crossref: 25] [Cited by in F6Publishing: 24] [Article Influence: 3.1] [Reference Citation Analysis]
23 Zhong ZD, Jiang LL, Khandelwal P, Clarke AW, Bakhtiar R, Zou L. Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies. AAPS J 2020;22:36. [PMID: 31997031 DOI: 10.1208/s12248-020-0413-z] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 0.5] [Reference Citation Analysis]
24 Song S, Yang L, Trepicchio WL, Wyant T. Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance. J Immunol Res 2016;2016:3072586. [PMID: 27340678 DOI: 10.1155/2016/3072586] [Cited by in Crossref: 37] [Cited by in F6Publishing: 36] [Article Influence: 6.2] [Reference Citation Analysis]
25 Weeraratne DK, Lofgren J, Dinnogen S, Swanson SJ, Zhong ZD. Development of a biosensor-based immunogenicity assay capable of blocking soluble drug target interference. J Immunol Methods 2013;396:44-55. [PMID: 23933325 DOI: 10.1016/j.jim.2013.07.010] [Cited by in Crossref: 29] [Cited by in F6Publishing: 24] [Article Influence: 3.2] [Reference Citation Analysis]
26 Bano N, McKelvey T, Spear N, Yang TY, Shankar G, Schantz A. Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products. Bioanalysis 2019;11:2283-96. [PMID: 31845602 DOI: 10.4155/bio-2019-0241] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
27 Tatarewicz SM, Mytych DT, Manning MS, Swanson SJ, Moxness MS, Chirmule N. Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact. Bioanalysis 2014;6:1509-23. [DOI: 10.4155/bio.14.114] [Cited by in Crossref: 20] [Cited by in F6Publishing: 18] [Article Influence: 2.5] [Reference Citation Analysis]
28 Zheng J, Mehl J, Zhu Y, Xin B, Olah T. Application and challenges in using LC–MS assays for absolute quantitative analysis of therapeutic proteins in drug discovery. Bioanalysis 2014;6:859-79. [DOI: 10.4155/bio.14.36] [Cited by in Crossref: 40] [Cited by in F6Publishing: 36] [Article Influence: 5.0] [Reference Citation Analysis]
29 Liu XI, Dallmann A, Wang YM, Green DJ, Burnham JM, Chiang B, Wu P, Sheng M, Lu K, van den Anker JN, Burckart GJ. Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration. J Clin Pharmacol 2019;59:1130-43. [PMID: 30865317 DOI: 10.1002/jcph.1406] [Cited by in Crossref: 11] [Cited by in F6Publishing: 10] [Article Influence: 3.7] [Reference Citation Analysis]
30 Zhong ZD, Clements-egan A, Gorovits B, Maia M, Sumner G, Theobald V, Wu Y, Rajadhyaksha M. Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies. AAPS J 2017;19:1564-75. [DOI: 10.1208/s12248-017-0148-7] [Cited by in Crossref: 18] [Cited by in F6Publishing: 15] [Article Influence: 3.6] [Reference Citation Analysis]