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Items: 46

1.

Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays.

Kubiak RJ, Arends RH, Lee N, Liang M, Zhang J, Roskos LK.

Bioanalysis. 2020 Feb;12(4):245-256. doi: 10.4155/bio-2019-0283. Epub 2020 Feb 24.

2.

A novel approach to assess domain specificity of anti-drug antibodies to moxetumomab pasudotox, an immunotoxin with two functional domains.

Vainshtein I, Sun B, Roskos LK, Liang M.

J Immunol Methods. 2020 Feb;477:112688. doi: 10.1016/j.jim.2019.112688. Epub 2019 Oct 30.

PMID:
31676342
3.

Patient-reported outcomes and inflammatory biomarkers in patients with locally advanced/metastatic urothelial carcinoma treated with durvalumab in phase 1/2 dose-escalation study 1108.

O'Donnell PH, Arkenau HT, Sridhar SS, Ong M, Drakaki A, Spira AI, Zhang J, Gordon MS, Degboe AN, Gupta AK, Mukhopadhyay P, Huang W, Abdullah SE, Angra N, Roskos LK, Guo X, Friedlander T.

Cancer. 2020 Jan 15;126(2):432-443. doi: 10.1002/cncr.32532. Epub 2019 Oct 3.

PMID:
31581306
4.

Population Pharmacokinetic Modeling of Benralizumab in Adult and Adolescent Patients with Asthma.

Yan L, Wang B, Chia YL, Roskos LK.

Clin Pharmacokinet. 2019 Jul;58(7):943-958. doi: 10.1007/s40262-019-00738-4.

5.

Pharmacodynamic biomarkers and differential effects of TNF- and GM-CSF-targeting biologics in rheumatoid arthritis.

Guo X, Wang S, Godwood A, Close D, Ryan PC, Roskos LK, White WI.

Int J Rheum Dis. 2019 Apr;22(4):646-653. doi: 10.1111/1756-185X.13395. Epub 2018 Oct 24.

6.

Excessive outlier removal may result in cut points that are not suitable for immunogenicity assessments.

Kubiak RJ, Zhang J, Ren P, Yang H, Roskos LK.

J Immunol Methods. 2018 Dec;463:105-111. doi: 10.1016/j.jim.2018.10.001. Epub 2018 Oct 9.

7.

Submicron Size Particles of a Murine Monoclonal Antibody Are More Immunogenic Than Soluble Oligomers or Micron Size Particles Upon Subcutaneous Administration in Mice.

Kijanka G, Bee JS, Korman SA, Wu Y, Roskos LK, Schenerman MA, Slütter B, Jiskoot W.

J Pharm Sci. 2018 Nov;107(11):2847-2859. doi: 10.1016/j.xphs.2018.06.029. Epub 2018 Jul 10.

PMID:
30003898
8.

Selection of a Ligand-Binding Neutralizing Antibody Assay for Benralizumab: Comparison with an Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Cell-Based Assay.

Wu Y, Akhgar A, Li JJ, Yu B, Chen C, Lee N, White WI, Roskos LK.

AAPS J. 2018 Mar 14;20(3):49. doi: 10.1208/s12248-018-0207-8.

PMID:
29541868
9.

Prevalence of IgG and Neutralizing Antibodies against Staphylococcus aureus Alpha-Toxin in Healthy Human Subjects and Diverse Patient Populations.

Wu Y, Liu X, Akhgar A, Li JJ, Mok H, Sellman BR, Yu L, Roskos LK, Esser MT, Ruzin A.

Infect Immun. 2018 Feb 20;86(3). pii: e00671-17. doi: 10.1128/IAI.00671-17. Print 2018 Mar.

10.

Blockade of GM-CSF pathway induced sustained suppression of myeloid and T cell activities in rheumatoid arthritis.

Guo X, Higgs BW, Bay-Jensen AC, Wu Y, Karsdal MA, Kuziora M, Godwood A, Close D, Ryan PC, Roskos LK, White WI.

Rheumatology (Oxford). 2018 Jan 1;57(1):175-184. doi: 10.1093/rheumatology/kex383.

PMID:
29069507
11.

Population Pharmacokinetics and Pharmacodynamics of Benralizumab in Healthy Volunteers and Patients With Asthma.

Wang B, Yan L, Yao Z, Roskos LK.

CPT Pharmacometrics Syst Pharmacol. 2017 Apr;6(4):249-257. doi: 10.1002/psp4.12160. Epub 2017 Jan 21.

12.

Immunogenicity assay cut point determination using nonparametric tolerance limit.

Zhang J, Li W, Roskos LK, Yang H.

J Immunol Methods. 2017 Mar;442:29-34. doi: 10.1016/j.jim.2017.01.001. Epub 2017 Jan 5.

PMID:
28063769
14.

An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox.

Schneider AK, Vainshtein I, Roskos LK, Chavez C, Sun B, Liang M.

J Immunol Methods. 2016 Aug;435:68-76. doi: 10.1016/j.jim.2016.05.007. Epub 2016 May 21.

PMID:
27220271
15.

Pharmacological profile of MEDI-551, a novel anti-CD19 antibody, in human CD19 transgenic mice.

Gallagher S, Turman S, Yusuf I, Akhgar A, Wu Y, Roskos LK, Herbst R, Wang Y.

Int Immunopharmacol. 2016 Jul;36:205-212. doi: 10.1016/j.intimp.2016.04.035. Epub 2016 May 7.

PMID:
27163209
16.

Multiplexing of receptor occupancy measurements for pharmacodynamic biomarker assessment of biopharmaceuticals.

Vainshtein I, Schneider AK, Sun B, Schwickart M, Roskos LK, Liang M.

Cytometry B Clin Cytom. 2016 Mar;90(2):128-40. doi: 10.1002/cyto.b.21319. Epub 2015 Oct 15.

17.

A Neutralizing Antibody Assay Based on a Reporter of Antibody-Dependent Cell-Mediated Cytotoxicity.

Wu Y, Li JJ, Kim HJ, Liu X, Liu W, Akhgar A, Bowen MA, Spitz S, Jiang XR, Roskos LK, White WI.

AAPS J. 2015 Nov;17(6):1417-26. doi: 10.1208/s12248-015-9798-5. Epub 2015 Jul 24.

18.

Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development.

Liang M, Schwickart M, Schneider AK, Vainshtein I, Del Nagro C, Standifer N, Roskos LK.

Cytometry B Clin Cytom. 2016 Mar;90(2):117-27. doi: 10.1002/cyto.b.21259. Epub 2015 Jul 31. Review.

19.

Suppression of T Cell Activation and Collagen Accumulation by an Anti-IFNAR1 mAb, Anifrolumab, in Adult Patients with Systemic Sclerosis.

Guo X, Higgs BW, Bay-Jensen AC, Karsdal MA, Yao Y, Roskos LK, White WI.

J Invest Dermatol. 2015 Oct;135(10):2402-2409. doi: 10.1038/jid.2015.188. Epub 2015 May 20.

20.

Quantitative measurement of the target-mediated internalization kinetics of biopharmaceuticals.

Vainshtein I, Roskos LK, Cheng J, Sleeman MA, Wang B, Liang M.

Pharm Res. 2015 Jan;32(1):286-99. doi: 10.1007/s11095-014-1462-8. Epub 2014 Sep 11.

21.

Suppression of soluble T cell-associated proteins by an anti-interferon-α monoclonal antibody in adult patients with dermatomyositis or polymyositis.

Guo X, Higgs BW, Rebelatto M, Zhu W, Greth W, Yao Y, Roskos LK, White WI.

Rheumatology (Oxford). 2014 Apr;53(4):686-95. doi: 10.1093/rheumatology/ket413. Epub 2013 Dec 19.

22.

An electrochemiluminescence (ECL)-based assay for the specific detection of anti-drug antibodies of the IgE isotype.

Wu Y, Liu X, Chen Y, Woods R, Lee N, Yang H, Chowdhury P, Roskos LK, White WI.

J Pharm Biomed Anal. 2013 Dec;86:73-81. doi: 10.1016/j.jpba.2013.06.005. Epub 2013 Jun 28.

PMID:
23988731
23.

Population pharmacokinetics of sifalimumab, an investigational anti-interferon-α monoclonal antibody, in systemic lupus erythematosus.

Narwal R, Roskos LK, Robbie GJ.

Clin Pharmacokinet. 2013 Nov;52(11):1017-27. doi: 10.1007/s40262-013-0085-2.

24.

Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays.

Kubiak RJ, Zhang L, Zhang J, Zhu Y, Lee N, Weichold FF, Yang H, Abraham V, Akufongwe PF, Hewitt L, Robinson S, Liu W, Liu X, Patnaik MM, Spitz S, Wu Y, Roskos LK.

J Pharm Biomed Anal. 2013 Feb 23;74:235-45. doi: 10.1016/j.jpba.2012.10.027. Epub 2012 Nov 2.

PMID:
23245256
25.

Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children.

Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK.

Antimicrob Agents Chemother. 2012 Sep;56(9):4927-36. doi: 10.1128/AAC.06446-11. Epub 2012 Jul 16. Erratum in: Antimicrob Agents Chemother. 2012 Oct;56(10):5431.

26.

PK-PD modeling of protein drugs: implications in assay development.

Roskos LK, Schneider A, Vainshtein I, Schwickart M, Lee R, Lu H, Faggioni R, Liang M.

Bioanalysis. 2011 Mar;3(6):659-75. doi: 10.4155/bio.11.28. Review.

PMID:
21417734
27.

An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males.

Oh CK, Faggioni R, Jin F, Roskos LK, Wang B, Birrell C, Wilson R, Molfino NA.

Br J Clin Pharmacol. 2010 Jun;69(6):645-55. doi: 10.1111/j.1365-2125.2010.03647.x.

28.

Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms.

Liang M, Klakamp SL, Funelas C, Lu H, Lam B, Herl C, Umble A, Drake AW, Pak M, Ageyeva N, Pasumarthi R, Roskos LK.

Assay Drug Dev Technol. 2007 Oct;5(5):655-62.

PMID:
17939757
29.

Application of analytical detection concepts to immunogenicity testing.

Klakamp SL, Lu H, Tabrizi M, Funelas C, Roskos LK, Coleman D.

Anal Chem. 2007 Nov 1;79(21):8176-84. Epub 2007 Oct 9.

PMID:
17922557
30.

Preclinical and clinical safety of monoclonal antibodies.

Tabrizi MA, Roskos LK.

Drug Discov Today. 2007 Jul;12(13-14):540-7. Epub 2007 Jun 27. Review.

PMID:
17631248
31.

Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects.

Roskos LK, Lum P, Lockbaum P, Schwab G, Yang BB.

J Clin Pharmacol. 2006 Jul;46(7):747-57.

PMID:
16809800
32.

Elimination mechanisms of therapeutic monoclonal antibodies.

Tabrizi MA, Tseng CM, Roskos LK.

Drug Discov Today. 2006 Jan;11(1-2):81-8. Review.

PMID:
16478695
33.

Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats.

Yang BB, Lum PK, Hayashi MM, Roskos LK.

J Pharm Sci. 2004 May;93(5):1367-73.

PMID:
15067712
34.

Preclinical and clinical evaluations of ABX-EGF, a fully human anti-epidermal growth factor receptor antibody.

Foon KA, Yang XD, Weiner LM, Belldegrun AS, Figlin RA, Crawford J, Rowinsky EK, Dutcher JP, Vogelzang NJ, Gollub J, Thompson JA, Schwartz G, Bukowski RM, Roskos LK, Schwab GM.

Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):984-90. Review.

35.

Topiramate and phenytoin pharmacokinetics during repetitive monotherapy and combination therapy to epileptic patients.

Sachdeo RC, Sachdeo SK, Levy RH, Streeter AJ, Bishop FE, Kunze KL, Mather GG, Roskos LK, Shen DD, Thummel KE, Trager WF, Curtin CR, Doose DR, Gisclon LG, Bialer M.

Epilepsia. 2002 Jul;43(7):691-6. Erratum in: Epilepsia 2002 Oct;43(10):1273.

36.

Cyclic immune thrombocytopenia responsive to thrombopoietic growth factor therapy.

Rice L, Nichol JL, McMillan R, Roskos LK, Bacile M.

Am J Hematol. 2001 Nov;68(3):210-4.

37.

Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers.

Wang B, Ludden TM, Cheung EN, Schwab GG, Roskos LK.

J Pharmacokinet Pharmacodyn. 2001 Aug;28(4):321-42.

PMID:
11677930
38.

Treatment of steroid-refractory acute graft-versus-host disease with anti-CD147 monoclonal antibody ABX-CBL.

Deeg HJ, Blazar BR, Bolwell BJ, Long GD, Schuening F, Cunningham J, Rifkin RM, Abhyankar S, Briggs AD, Burt R, Lipani J, Roskos LK, White JM, Havrilla N, Schwab G, Heslop HE.

Blood. 2001 Oct 1;98(7):2052-8.

PMID:
11567989
39.

Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report.

Galluppi GR, Rogge MC, Roskos LK, Lesko LJ, Green MD, Feigal DW Jr, Peck CC.

Clin Pharmacol Ther. 2001 Jun;69(6):387-99. No abstract available.

PMID:
11406736
40.

Pharmacokinetic analysis of pegylated megakaryocyte growth and development factor in humans.

De Boer RH, Roskos LK, Cheung E, Fox S, Basser RL, Marty J, Begley CG, Cebon J.

Growth Factors. 2000;18(3):215-26.

PMID:
11334057
41.

A population approach to enzyme characterization and identification: application to phenacetin O-deethylation.

Belle DJ, Ring BJ, Allerheiligen SR, Heathman MA, O'Brien LM, Sinha V, Roskos LK, Wrighton SA.

Pharm Res. 2000 Dec;17(12):1531-6.

PMID:
11303964
42.

Effects of megakaryocyte growth and development factor on platelet production, platelet life span, and platelet function in healthy human volunteers.

Harker LA, Roskos LK, Marzec UM, Carter RA, Cherry JK, Sundell B, Cheung EN, Terry D, Sheridan W.

Blood. 2000 Apr 15;95(8):2514-22.

PMID:
10753829
43.

Roles of cytochrome P4502C9 and cytochrome P4502C19 in the stereoselective metabolism of phenytoin to its major metabolite.

Bajpai M, Roskos LK, Shen DD, Levy RH.

Drug Metab Dispos. 1996 Dec;24(12):1401-3. No abstract available.

PMID:
8971149
44.

Identification of the human cytochromes P450 responsible for the in vitro formation of the major oxidative metabolites of the antipsychotic agent olanzapine.

Ring BJ, Catlow J, Lindsay TJ, Gillespie T, Roskos LK, Cerimele BJ, Swanson SP, Hamman MA, Wrighton SA.

J Pharmacol Exp Ther. 1996 Feb;276(2):658-66.

PMID:
8632334
45.

Inhibition of the enantioselective oxidative metabolism of metoprolol by verapamil in human liver microsomes.

Kim M, Shen DD, Eddy AC, Nelson WL, Roskos LK.

Drug Metab Dispos. 1993 Mar-Apr;21(2):309-17. Erratum in: Drug Metab Dispos Biol Fate Chem 1993 Sep-Oct;21(5):970.

PMID:
8097702
46.

Effects of dose and sex on the pharmacokinetics of piroxicam in the rat.

Roskos LK, Boudinot FD.

Biopharm Drug Dispos. 1990 Apr;11(3):215-25.

PMID:
2328308

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