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Page 1
An Integrated Analysis of Dostarlimab Immunogenicity.
Lu S, Bowsher RR, Clancy A, Rosen A, Zhang M, Yang Y, Koeck K, Gao M, Potocka E, Guo W, Jen KY, Im E, Milton A. Lu S, et al. Among authors: bowsher rr. AAPS J. 2021 Jul 29;23(5):96. doi: 10.1208/s12248-021-00624-7. AAPS J. 2021. PMID: 34324079 Free PMC article. Clinical Trial.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. Among authors: bowsher rr. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.
Erratum to: Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. Marini JC, et al. Among authors: bowsher rr. AAPS J. 2017 May;19(3):883. doi: 10.1208/s12248-017-0074-8. AAPS J. 2017. PMID: 28374318 No abstract available.
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
Sun B, Sengupta N, Rao A, Donnelly C, Waichale V, Roy AS, Ramaswamy S, Pathak D, Bowsher RR, Raiter Y, Aubonnet P, Barve A. Sun B, et al. Among authors: bowsher rr. BMC Endocr Disord. 2021 Jun 26;21(1):129. doi: 10.1186/s12902-021-00797-4. BMC Endocr Disord. 2021. PMID: 34174848 Free PMC article. Clinical Trial.
Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.
Marini JC, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher RR. Marini JC, et al. Among authors: bowsher rr. AAPS J. 2014 Nov;16(6):1149-58. doi: 10.1208/s12248-014-9669-5. Epub 2014 Oct 3. AAPS J. 2014. PMID: 25277165 Free PMC article.
Development and validation of a noncompetitive electrochemiluminescence-based immunoassay (ECLIA) for specific determination of insulin lispro (Humalog®) in human serum to support pharmacokinetic assessments.
Simmons E, Johnson D, Delhaye R, Colwell J, Clor E, Santa P, Bowsher RR. Simmons E, et al. Among authors: bowsher rr. J Immunoassay Immunochem. 2019;40(3):314-327. doi: 10.1080/15321819.2019.1596950. Epub 2019 Mar 29. J Immunoassay Immunochem. 2019. PMID: 30924380
105 results