Baltrukonis D - Search Results

1

Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study.

McCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. McCush F, et al. Among authors: baltrukonis d. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x. AAPS J. 2023. PMID: 37658997

2

Comparative Pharmacokinetics and Pharmacodynamics of Bococizumab Following a Single Subcutaneous Injection Using Drug Substance Manufactured at Two Sites or Administration via Two Different Devices.

Wang EQ, Plotka A, Salageanu J, Baltrukonis D, Mridha K, Frederich R, Sullivan BE. Wang EQ, et al. Among authors: baltrukonis d. Clin Pharmacol Drug Dev. 2019 Jan;8(1):40-48. doi: 10.1002/cpdd.454. Epub 2018 Apr 24. Clin Pharmacol Drug Dev. 2019. PMID: 29688615 Clinical Trial.

3

Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis.

Gorovits B, Roldan MA, Baltrukonis D, Cai CH, Donley J, Jani D, Kamerud J, McCush F, Thomas JS, Wang Y. Gorovits B, et al. Among authors: baltrukonis d. AAPS J. 2019 Jun 18;21(5):76. doi: 10.1208/s12248-019-0347-5. AAPS J. 2019. PMID: 31214862

4

Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies.

Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Wang EQ, et al. Among authors: baltrukonis d. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0. BioDrugs. 2019. PMID: 31529318 Free PMC article.

5

Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population.

Tan CY, Steeno GS, You Z, Gaitonde P, Cai CH, Kamerud J, Gorovits B, Baltrukonis DJ. Tan CY, et al. Among authors: baltrukonis dj. AAPS J. 2020 Jan 3;22(2):19. doi: 10.1208/s12248-019-0400-4. AAPS J. 2020. PMID: 31900604

6

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: baltrukonis d. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. AAPS J. 2023. PMID: 37421491

7

A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation.

Qu Q, Liu S, You Z, Steeno GS, Dyleski LA, Mu X, Wang Y, Baltrukonis D. Qu Q, et al. Among authors: baltrukonis d. AAPS J. 2024 Jul 31;26(5):88. doi: 10.1208/s12248-024-00959-x. AAPS J. 2024. PMID: 39085624

8

Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.

Dudal S, Baltrukonis D, Crisino R, Goyal MJ, Joyce A, Osterlund K, Smeraglia J, Taniguchi Y, Yang J. Dudal S, et al. Among authors: baltrukonis d. AAPS J. 2014 Mar;16(2):194-205. doi: 10.1208/s12248-013-9552-9. Epub 2013 Dec 17. AAPS J. 2014. PMID: 24343771 Free PMC article. Review.

9

Immunoassay methods used in clinical studies for the detection of anti-drug antibodies to adalimumab and infliximab.

Gorovits B, Baltrukonis DJ, Bhattacharya I, Birchler MA, Finco D, Sikkema D, Vincent MS, Lula S, Marshall L, Hickling TP. Gorovits B, et al. Among authors: baltrukonis dj. Clin Exp Immunol. 2018 Jun;192(3):348-365. doi: 10.1111/cei.13112. Epub 2018 Mar 30. Clin Exp Immunol. 2018. PMID: 29431871 Free PMC article. Review.

10

Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics.

Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR 3rd, Lowe J, Maia M, Wong T. Finco D, et al. Among authors: baltrukonis d. J Pharm Biomed Anal. 2011 Jan 25;54(2):351-8. doi: 10.1016/j.jpba.2010.08.029. Epub 2010 Sep 21. J Pharm Biomed Anal. 2011. PMID: 20863644

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