179 related articles for article (PubMed ID: 32022282)
1. 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
Br J Clin Pharmacol; 2020 Jun; 86(6):1139-1149. PubMed ID: 32022282
[TBL] [Abstract][Full Text] [Related]
2. PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta
Moosavi S; Borema T; Ewesuedo R; Harris S; Levy J; May TB; Summers M; Thomas JS; Zhang J; Yao HM
Adv Ther; 2020 Jul; 37(7):3370-3391. PubMed ID: 32524499
[TBL] [Abstract][Full Text] [Related]
3. Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects.
Nakov R; Gattu S; Wang J; Velinova M; Schaffar G; Skerjanec A
Br J Clin Pharmacol; 2018 Dec; 84(12):2790-2801. PubMed ID: 30079636
[TBL] [Abstract][Full Text] [Related]
4. Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.
Gattu S; Wang J; Bellon A; Schelcher C; Nakov R; Arani R
Clin Pharmacol Drug Dev; 2021 Oct; 10(10):1130-1141. PubMed ID: 34350732
[TBL] [Abstract][Full Text] [Related]
5. 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. PubMed ID: 29671069
[TBL] [Abstract][Full Text] [Related]
6. Pharmacokinetics and pharmacodynamics of a proposed tocilizumab biosimilar MSB11456 versus both the US-licensed and EU-approved products: a randomized, double-blind trial.
Schwabe C; Illes A; Ullmann M; Ghori V; Vincent E; Petit-Frere C; Monnet J; Racault AS; Wynne C
Expert Rev Clin Immunol; 2022 May; 18(5):533-543. PubMed ID: 35354411
[TBL] [Abstract][Full Text] [Related]
7. LA-EP2006: A Pegfilgrastim Biosimilar.
Hoy SM
BioDrugs; 2019 Apr; 33(2):229-232. PubMed ID: 30887256
[TBL] [Abstract][Full Text] [Related]
8. A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006).
Agarwala SS; Nagl U; Guo X; Bellon A; Heyn J; Dimova-Dobreva M; Shen YM; Schaffar G; Humphrey M; Mathieson N; Koptelova N; Gattu S
Curr Med Res Opin; 2022 Jun; 38(6):999-1009. PubMed ID: 35392751
[TBL] [Abstract][Full Text] [Related]
9. 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
Oncologist; 2016 Jul; 21(7):789-94. PubMed ID: 27091420
[TBL] [Abstract][Full Text] [Related]
10. Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial.
Lickliter J; Kanceva R; Vincent E; Schueler A; Harrison-Moench E; Yue CS; Stahl M; Ullmann M; Ghori V; Griffin P
Clin Ther; 2020 Aug; 42(8):1508-1518.e1. PubMed ID: 32660769
[TBL] [Abstract][Full Text] [Related]
11. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg
Roth K; Lehnick D; Wessels H; Höfler J; Gastl B; Jankowsky R
Pharmacol Res Perspect; 2019 Oct; 7(5):e00503. PubMed ID: 31417680
[TBL] [Abstract][Full Text] [Related]
12. 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. PubMed ID: 27138868
[TBL] [Abstract][Full Text] [Related]
13. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Blackwell K; Gascon P; Jones CM; Nixon A; Krendyukov A; Nakov R; Li Y; Harbeck N
Ann Oncol; 2017 Sep; 28(9):2272-2277. PubMed ID: 28637287
[TBL] [Abstract][Full Text] [Related]
14. Pharmacodynamics, safety, and immunogenicity of Pelmeg
Wessels H; Lehnick D; Höfler J; Jankowsky R; Chamberlain P; Roth K
Pharmacol Res Perspect; 2019 Oct; 7(5):e00507. PubMed ID: 31417681
[TBL] [Abstract][Full Text] [Related]
15. A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants.
Tang H; Civoli F; Tatarewicz S; Vandenkoornhuyse N; Finck B
Adv Ther; 2024 Mar; 41(3):991-1009. PubMed ID: 38180721
[TBL] [Abstract][Full Text] [Related]
16. Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy.
Kahan Z; Grecea D; Smakal M; Tjulandin S; Bondarenko I; Perjesi L; Illes A; Horvat-Karajz K; Aradi I
BMC Cancer; 2019 Feb; 19(1):122. PubMed ID: 30727980
[TBL] [Abstract][Full Text] [Related]
17. Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar.
Hoy SM
BioDrugs; 2019 Feb; 33(1):117-120. PubMed ID: 30701419
[TBL] [Abstract][Full Text] [Related]
18. Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.
Finck B; Tang H; Civoli F; Hodge J; O'Kelly H; Vexler V
Adv Ther; 2020 Oct; 37(10):4291-4307. PubMed ID: 32789809
[TBL] [Abstract][Full Text] [Related]
19. Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta
Wynne C; Schwabe C; Vincent E; Schueler A; Ryding J; Ullmann M; Ghori V; Kanceva R; Stahl M
Pharmacol Res Perspect; 2020 Apr; 8(2):e00578. PubMed ID: 32333641
[TBL] [Abstract][Full Text] [Related]
20. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy.
Desai K; Misra P; Kher S; Shah N
Exp Hematol Oncol; 2018; 7():22. PubMed ID: 30202638
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]