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Items: 1 to 20 of 99

1.

Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers.

Choi C, Yoo BW, Kim CO, Hong T, Jin BH, Seo KS, Jang JY, Park MS.

Drug Des Devel Ther. 2018 Aug 1;12:2381-2387. doi: 10.2147/DDDT.S158277. eCollection 2018.

2.
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Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial.

Lubenau H, Bias P, Maly AK, Siegler KE, Mehltretter K.

BioDrugs. 2009;23(1):43-51. doi: 10.2165/00063030-200923010-00005.

PMID:
19344191
4.

A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.

Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ.

J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18.

PMID:
29671069
5.

A comparative pharmacokinetic and pharmacodynamic study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese men.

Matsuguma K, Matsuki S, Sakamoto K, Shiramoto M, Nakagawa M, Kimura M, Irie S, Kaneko D, Ohnishi A.

Clin Pharmacol Drug Dev. 2015 Mar;4(2):99-104. doi: 10.1002/cpdd.178. Epub 2015 Jan 22.

PMID:
27128214
6.

Safety and Biosimilarity of ior®LeukoCIM Compared to Neupogen® Based on Toxicity, Pharmacodynamic, and Pharmacokinetic Studies in the Sprague-Dawley Rat.

Licollari A, Riddle K, Taylor SR, Ledon N, Bolger GT.

J Pharm Sci. 2017 Jun;106(6):1475-1481. doi: 10.1016/j.xphs.2017.02.009. Epub 2017 Feb 24.

PMID:
28238900
7.

Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim.

Desai K, Catalano T, Rai G, Misra P, Shah N.

Clin Pharmacol Drug Dev. 2016 Sep;5(5):354-63. doi: 10.1002/cpdd.269. Epub 2016 Jun 17.

8.

Pharmacokinetic and pharmacodynamic bioequivalence study of a pegfilgrastim biosimilar INTP5 in healthy subjects.

Singh I, Patel A, Patel R, Jose V.

Cancer Chemother Pharmacol. 2018 Aug;82(2):329-337. doi: 10.1007/s00280-018-3620-x. Epub 2018 Jun 15.

PMID:
29948023
9.

Pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects.

Matsuguma K, Matsuki S, Eunhee C, Watanabe A, Tanaka A, Sakamoto K, Takeshita H, Hitaka A, Shigetome K, Kimura M, Miyamoto A, Irie S, Kaneko D, Ohnishi A.

Drug Dev Ind Pharm. 2015 Mar;41(3):470-5. doi: 10.3109/03639045.2013.879721. Epub 2014 Jan 28.

PMID:
24471477
10.

Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen®.

Crobu D, Spinetti G, Schrepfer R, Tonon G, Jotti GS, Onali P, Dedoni S, Orsini G, Di Stefano A.

BMC Pharmacol Toxicol. 2014 Feb 21;15:7. doi: 10.1186/2050-6511-15-7.

11.

Comparison of the pharmacokinetic and pharmacodynamic properties of two recombinant granulocyte colony-stimulating factor formulations after single subcutaneous administration to healthy volunteers.

Sveikata A, Gumbrevičius G, Seštakauskas K, Kregždytė R, Janulionis V, Fokas V.

Medicina (Kaunas). 2014;50(3):144-9. doi: 10.1016/j.medici.2014.08.001. Epub 2014 Aug 13.

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13.

Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.

Sörgel F, Schwebig A, Holzmann J, Prasch S, Singh P, Kinzig M.

BioDrugs. 2015 Apr;29(2):123-31. doi: 10.1007/s40259-015-0124-7.

14.

Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial.

Waller CF, Bronchud M, Mair S, Challand R.

Ann Hematol. 2010 Oct;89(10):971-8. doi: 10.1007/s00277-010-0973-6. Epub 2010 Jun 22.

15.

Evaluation of the efficacy and safety of original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) in CD34(+) peripheral hematopoietic stem cell mobilization procedures for allogeneic hematopoietic stem cell transplant donors.

Sivgin S, Karakus E, Keklik M, Zararsiz G, Solmaz M, Kaynar L, Eser B, Cetin M, Unal A.

Transfus Apher Sci. 2016 Jun;54(3):410-5. doi: 10.1016/j.transci.2016.03.003. Epub 2016 Mar 24.

PMID:
27052362
16.

Bioequivalence of a biosimilar enoxaparin sodium to Clexane® after single 100 mg subcutaneous dose: results of a randomized, double-blind, crossover study in healthy volunteers.

Martínez González J, Monreal M, Ayani Almagia I, Llaudó Garín J, Ochoa Díaz de Monasterioguren L, Gutierro Adúriz I.

Drug Des Devel Ther. 2018 Mar 19;12:575-582. doi: 10.2147/DDDT.S162817. eCollection 2018.

17.

Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N.

Ann Oncol. 2015 Sep;26(9):1948-53. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.

18.

Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial.

Waller CF, Bronchud M, Mair S, Challand R.

Ann Hematol. 2010 Sep;89(9):927-33. doi: 10.1007/s00277-010-0961-x. Epub 2010 Apr 29.

19.

Development of a new G-CSF product based on biosimilarity assessment.

Gascon P, Fuhr U, Sörgel F, Kinzig-Schippers M, Makhson A, Balser S, Einmahl S, Muenzberg M.

Ann Oncol. 2010 Jul;21(7):1419-29. doi: 10.1093/annonc/mdp574. Epub 2009 Dec 17.

PMID:
20019087
20.

Recombinant filgrastim (BK0023) pharmacodynamics and pharmacokinetics after single and multiple escalating doses in an equivalence study in healthy men.

Di Stefano AF, Spinetti G, Rusca A, Radicioni MM, Loprete L, Lamparelli DM, Michael Hepp J, Crobu D, Schrepfer R, Tonon G.

Clin Drug Investig. 2015 Sep;35(9):533-45. doi: 10.1007/s40261-015-0310-x.

PMID:
26251016

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