These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

163 related articles for article (PubMed ID: 34794342)

  • 1. A comparative multi-tiered immunogenicity assessment of biosimilar pegylated filgrastim: validation of methods for clinical assessment of INTP5.
    Hajela P; Patel R; Kale P; Kumar M; Khambhampaty S
    Expert Opin Biol Ther; 2022 Feb; 22(2):321-330. PubMed ID: 34794342
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Single-Dose Pharmacokinetics, Pharmacodynamics and Immunogenicity, and Multiple-Dose Immunogenicity of INTP5 (Pegfilgrastim Biosimilar) Versus Reference Pegfilgrastim in Healthy Subjects.
    Singh I; Attrey A; Garg A; Patel R; Jose V
    Clin Drug Investig; 2021 Jan; 41(1):29-42. PubMed ID: 33236287
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies.
    Civoli F; Finck B; Tang H; Hodge J; O'Kelly H; Vexler V
    Adv Ther; 2022 Mar; 39(3):1230-1246. PubMed ID: 35034311
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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. PubMed ID: 29948023
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. 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]  

  • 7. 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]  

  • 8. Comparison of effectiveness of biosimilar filgrastim (Nivestim™), reference Amgen filgrastim and pegfilgrastim in febrile neutropenia primary prevention in breast cancer patients treated with neo(adjuvant) TAC: a non-interventional cohort study.
    Brito M; Esteves S; André R; Isidoro M; Moreira A
    Support Care Cancer; 2016 Feb; 24(2):597-603. PubMed ID: 26111956
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment.
    Gouty D; Cai CC; Cai XY; Kasinath A; Kumar V; Alvandkouhi S; Yang J; Pederson S; Babbitt B; Peritt D; Rudy A; Koppenburg V; Dasilva A; Ullmann M; Liu S; Satterwhite C
    AAPS J; 2017 Dec; 20(1):25. PubMed ID: 29285735
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma.
    McBride A; Krendyukov A; Mathieson N; Campbell K; Balu S; Natek M; MacDonald K; Abraham I
    J Med Econ; 2020 Jan; 23(1):28-36. PubMed ID: 31433700
    [No Abstract]   [Full Text] [Related]  

  • 11. A demonstration of analytical similarity comparing a proposed biosimilar pegfilgrastim and reference pegfilgrastim.
    Brokx S; Scrocchi L; Shah N; Dowd J
    Biologicals; 2017 Jul; 48():28-38. PubMed ID: 28619479
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States.
    Cheng CA; Jiang AL; Liu YR; Chang LC
    Clin Pharmacol Ther; 2023 Dec; 114(6):1274-1284. PubMed ID: 37634125
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. 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]  

  • 15. Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.
    Civoli F; Kasinath A; Cai XY; Wadhwa M; Exley A; Oldfield P; Alvandkouhi S; Schaffar G; Chappell J; Bowsher R; Devanarayan V; Marini J; Rebarchak S; Anderson M; Koppenburg V; Lester T
    AAPS J; 2019 Dec; 22(1):7. PubMed ID: 31792633
    [TBL] [Abstract][Full Text] [Related]  

  • 16. RGB-02 (biosimilar pegfilgrastim) in the treatment of chemotherapy-induced neutropenia.
    Sántha D; Illés A; Aradi I; Horvát-Karajz K; Kahán Z
    Future Oncol; 2019 Jun; 15(18):2083-2092. PubMed ID: 31210542
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.
    Na H; Kwon SH; Son KH; Baek Y; Kim J; Lee EK
    BioDrugs; 2023 Mar; 37(2):205-218. PubMed ID: 36729329
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Achieving white blood cell equity: are the safety profiles of biosimilar and reference pegfilgrastims comparable?
    Loaiza-Bonilla A; Page RD
    Future Oncol; 2024 Jan; 20(3):145-158. PubMed ID: 37609795
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure.
    Cornes P; Gascon P; Vulto AG; Aapro M
    BioDrugs; 2020 Jun; 34(3):255-263. PubMed ID: 32232676
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia.
    McBride A; Campbell K; Bikkina M; MacDonald K; Abraham I; Balu S
    J Med Econ; 2017 Oct; 20(10):1083-1093. PubMed ID: 28722494
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.