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Items: 1 to 20 of 95

1.

A novel pharmacokinetic bridging strategy to support a change in the route of administration for biologics.

Ji P, Nikolov N, Seymour S, Glaser R, Ren Y, Li L, Marathe A, Ren Y, Chen J, He L, Pisal D, Senarath Yapa SW, Wang Y, Sahajwalla C.

J Pharm Sci. 2019 Mar 11. pii: S0022-3549(19)30146-7. doi: 10.1016/j.xphs.2019.02.027. [Epub ahead of print]

PMID:
30871994
2.

Comparison of intravenous and subcutaneous exposure supporting dose selection of subcutaneous belimumab systemic lupus erythematosus Phase 3 program.

Yapa SW, Roth D, Gordon D, Struemper H.

Lupus. 2016 Nov;25(13):1448-1455. doi: 10.1177/0961203316642309. Epub 2016 Jul 11.

3.

Pharmacokinetic and Pharmacodynamic Analysis of Subcutaneous Tocilizumab in Patients With Rheumatoid Arthritis From 2 Randomized, Controlled Trials: SUMMACTA and BREVACTA.

Abdallah H, Hsu JC, Lu P, Fettner S, Zhang X, Douglass W, Bao M, Rowell L, Burmester GR, Kivitz A.

J Clin Pharmacol. 2017 Apr;57(4):459-468. doi: 10.1002/jcph.826. Epub 2016 Nov 17.

4.

Population Pharmacokinetics and Exposure-Response Relationship of Intravenous and Subcutaneous Abatacept in Patients With Rheumatoid Arthritis.

Li X, Roy A, Murthy B.

J Clin Pharmacol. 2019 Feb;59(2):245-257. doi: 10.1002/jcph.1308. Epub 2018 Sep 19.

PMID:
30229926
5.

Evaluation of etanercept dose reduction in patients with rheumatoid arthritis using pharmacokinetic/pharmacodynamic modeling and simulation.

Hsu LF, Huang JD.

Int J Clin Pharmacol Ther. 2014 Sep;52(9):776-86. doi: 10.5414/CP202131.

PMID:
24887337
6.

Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study.

Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, Teoh LS, Velagapudi RB, Noertersheuser PA, Granneman GR, Fischkoff SA, Chartash EK.

Clin Ther. 2003 Jun;25(6):1700-21.

PMID:
12860493
7.

Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.

Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X.

Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.

PMID:
26947201
8.

Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study.

Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-CĂ©ligny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D.

Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.

PMID:
24521993
10.

Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study.

Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G.

J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.

PMID:
24821885
11.

Efficacy and Safety of Subcutaneous and Intravenous Loading Dose Regimens of Secukinumab in Patients with Active Rheumatoid Arthritis: Results from a Randomized Phase II Study.

Tlustochowicz W, Rahman P, Seriolo B, Krammer G, Porter B, Widmer A, Richards HB.

J Rheumatol. 2016 Mar;43(3):495-503. doi: 10.3899/jrheum.150117. Epub 2016 Feb 1.

PMID:
26834211
12.

Model-based determination of abatacept exposure in support of the recommended dose for Japanese rheumatoid arthritis patients.

Hasegawa M, Imai Y, Hiraoka M, Ito K, Roy A.

J Pharmacokinet Pharmacodyn. 2011 Dec;38(6):803-32. doi: 10.1007/s10928-011-9221-5. Epub 2011 Oct 15.

PMID:
22002809
13.

Use of a population pharmacokinetic approach for the clinical development of a fixed-dose subcutaneous formulation of trastuzumab.

Hourcade-Potelleret F, Lemenuel-Diot A, McIntyre C, Brewster M, Lum B, Bittner B.

CPT Pharmacometrics Syst Pharmacol. 2014 Jan 2;3:e87. doi: 10.1038/psp.2013.63.

14.

Simultaneous Treatment with Subcutaneous Injection of Golimumab and Intra-articular Injection of Triamcinolone Acetonide (K-Method) in Patients with Rheumatoid Arthritis Undergoing Switching of Biologics: Retrospective Case-Control Study.

Kanbe K, Chiba J, Inoue Y, Taguchi M, Yabuki A, Deguchi T.

Clin Med Insights Arthritis Musculoskelet Disord. 2016 Apr 4;9:45-9. doi: 10.4137/CMAMD.S38442. eCollection 2016.

15.
16.

Population pharmacokinetic-pharmacodynamic modeling and dosing simulation of propofol maintenance anesthesia in severely obese adolescents.

Chidambaran V, Venkatasubramanian R, Sadhasivam S, Esslinger H, Cox S, Diepstraten J, Fukuda T, Inge T, Knibbe CAJ, Vinks AA.

Paediatr Anaesth. 2015 Sep;25(9):911-923. doi: 10.1111/pan.12684. Epub 2015 May 13.

17.

Switching biologics in the treatment of psoriatic arthritis.

Merola JF, Lockshin B, Mody EA.

Semin Arthritis Rheum. 2017 Aug;47(1):29-37. doi: 10.1016/j.semarthrit.2017.02.001. Epub 2017 Feb 8. Review.

18.

Bioavailability assessment of disopyramide using pharmacokinetic-pharmacodynamic (PK-PD) modeling in the rat.

Miyazaki M, Maekawa C, Iwanaga K, Morimoto K, Kakemi M.

Biol Pharm Bull. 2000 Nov;23(11):1363-9.

PMID:
11085367
19.

Potential patient benefit of a subcutaneous formulation of tocilizumab for the treatment of rheumatoid arthritis: a critical review.

Besada E.

Patient Prefer Adherence. 2014 Aug 1;8:1051-9. doi: 10.2147/PPA.S34958. eCollection 2014. Review.

20.

Clinical Pharmacokinetics and Pharmacodynamics of Biologic Therapeutics for Treatment of Systemic Lupus Erythematosus.

Yu T, Enioutina EY, Brunner HI, Vinks AA, Sherwin CM.

Clin Pharmacokinet. 2017 Feb;56(2):107-125. doi: 10.1007/s40262-016-0426-z. Review.

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