Civoli F - Search Results

1

Ligand binding assays in the 21st Century laboratory: automation.

Ahene AB, Morrow C, Rusnak D, Spitz S, Usansky J, Pils H, Civoli F, Pandya K, Sue B, Leach D, Derent J. Ahene AB, et al. Among authors: civoli f. AAPS J. 2012 Mar;14(1):142-53. doi: 10.1208/s12248-012-9323-z. AAPS J. 2012. PMID: 22302584 Free PMC article. No abstract available.

2

Development and characterization of a human antibody reference panel against erythropoietin suitable for the standardization of ESA immunogenicity testing.

Mytych DT, Barger TE, King C, Grauer S, Haldankar R, Hsu E, Wu MM, Shiwalkar M, Sanchez S, Kuck A, Civoli F, Sun J, Swanson SJ. Mytych DT, et al. Among authors: civoli f. J Immunol Methods. 2012 Aug 31;382(1-2):129-41. doi: 10.1016/j.jim.2012.05.013. Epub 2012 May 23. J Immunol Methods. 2012. PMID: 22634015

3

Neutralizing Antibody Validation Testing and Reporting Harmonization.

Myler H, Pedras-Vasconcelos J, Lester T, Civoli F, Xu W, Wu B, Vainshtein I, Luo L, Hassanein M, Liu S, Ramaswamy SS, Mora J, Pennucci J, McCush F, Lavelle A, Jani D, Ambakhutwala A, Baltrukonis D, Barker B, Carmean R, Chung S, Dai S, DeWall S, Dholakiya SL, Dodge R, Finco D, Yan H, Hays A, Hu Z, Inzano C, Kamen L, Lai CH, Meyer E, Nelson R, Paudel A, Phillips K, Poupart ME, Qu Q, Abhari MR, Ryding J, Sheldon C, Spriggs F, Warrino D, Wu Y, Yang L, Pasas-Farmer S. Myler H, et al. Among authors: civoli f. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. AAPS J. 2023. PMID: 37421491

4

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.

Civoli F, Kasinath A, Cai XY, Wadhwa M, Exley A, Oldfield P, Alvandkouhi S, Schaffar G, Chappell J, Bowsher R, Devanarayan V, Marini J, Rebarchak S, Anderson M, Koppenburg V, Lester T. Civoli F, et al. AAPS J. 2019 Dec 2;22(1):7. doi: 10.1208/s12248-019-0386-y. AAPS J. 2019. PMID: 31792633

5

Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Civoli F, et al. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16. Adv Ther. 2022. PMID: 35034311 Free PMC article. Clinical Trial.

6

Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.

Finck B, Tang H, Civoli F, Hodge J, O'Kelly H, Vexler V. Finck B, et al. Among authors: civoli f. Adv Ther. 2020 Oct;37(10):4291-4307. doi: 10.1007/s12325-020-01459-y. Epub 2020 Aug 13. Adv Ther. 2020. PMID: 32789809 Clinical Trial.

7

A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants.

Tang H, Civoli F, Tatarewicz S, Vandenkoornhuyse N, Finck B. Tang H, et al. Among authors: civoli f. Adv Ther. 2024 Mar;41(3):991-1009. doi: 10.1007/s12325-023-02735-3. Epub 2024 Jan 5. Adv Ther. 2024. PMID: 38180721 Free PMC article. Clinical Trial.

8

Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants.

Tang H, Civoli F, Tatarewicz S, Vandenkoornhuyse N, Finck B. Tang H, et al. Among authors: civoli f. Adv Ther. 2023 Nov;40(11):4889-4906. doi: 10.1007/s12325-023-02636-5. Epub 2023 Sep 14. Adv Ther. 2023. PMID: 37707674 Free PMC article. Clinical Trial.

9

Comparison of cell-based and non-cell-based assay platforms for the detection of clinically relevant anti-drug neutralizing antibodies for immunogenicity assessment of therapeutic proteins.

Hu J, Wala I, Han H, Nagatani J, Barger T, Civoli F, Kaliyaperumal A, Zhuang Y, Gupta S. Hu J, et al. Among authors: civoli f. J Immunol Methods. 2015 Apr;419:1-8. doi: 10.1016/j.jim.2015.02.006. Epub 2015 Mar 18. J Immunol Methods. 2015. PMID: 25795420

10

Development of a Novel BAFF Responsive Cell Line Suitable for Detecting Bioactive BAFF and Neutralizing Antibodies against BAFF-Pathway Inhibiting Therapeutics.

Hu J, Yu Y, Han H, Civoli F, Zhuang Y, Thomas J, Swanson S, Jing S, Gupta S. Hu J, et al. Among authors: civoli f. Cells. 2014 Feb 10;3(1):79-91. doi: 10.3390/cells3010079. Cells. 2014. PMID: 24709903 Free PMC article.

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