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A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.
Bellon A, Wang J, Skerjanec A, Velinova M, Dickerson D, Sabet A, Ngo L, O'Reilly T, Tomek C, Schussler S, Schier-Mumzhiu S, Gattu S, Koch SD, Schelcher C, Dobreva M, Boldea A, Nakov R, Otto GP. Bellon A, et al. Among authors: nakov r. Br J Clin Pharmacol. 2020 Jun;86(6):1139-1149. doi: 10.1111/bcp.14226. Epub 2020 Feb 21. Br J Clin Pharmacol. 2020. PMID: 32022282 Free PMC article. Clinical Trial.
A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.
Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascón P, Harbeck N. Blackwell K, et al. Among authors: nakov r. Oncologist. 2016 Jul;21(7):789-94. doi: 10.1634/theoncologist.2016-0011. Epub 2016 Apr 18. Oncologist. 2016. PMID: 27091420 Free PMC article. Clinical Trial.
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. Blackwell K, et al. Among authors: nakov r. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28. Ann Oncol. 2015. PMID: 26122726 Free PMC article. Clinical Trial.
75 results