BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

136 related articles for article (PubMed ID: 34850298)

  • 1. Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References.
    Song F; Zheng X; Wang Y; Chow SC; Sun H
    AAPS J; 2021 Nov; 24(1):3. PubMed ID: 34850298
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
    Tu CL; Wang YL; Hu TM; Hsu LF
    BioDrugs; 2019 Aug; 33(4):437-446. PubMed ID: 31111423
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Improving the power to establish clinical similarity in a Phase 3 efficacy trial by incorporating prior evidence of analytical and pharmacokinetic similarity.
    Zeng D; Pan J; Hu K; Chi E; Lin DY
    J Biopharm Stat; 2018; 28(2):320-332. PubMed ID: 29173074
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Design and Analysis of a Biosimilar Bridging Study with a Prediction Interval-Based Consistency Test.
    Pan Z; Huang W; Pan J; Koch G
    Ther Innov Regul Sci; 2021 Jul; 55(4):765-772. PubMed ID: 33797059
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins.
    Wang YC; Wang Y; Schrieber SJ; Earp J; Thway TM; Huang SM; Zineh I; Christl L
    J Pharm Sci; 2019 Jan; 108(1):73-77. PubMed ID: 30395832
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The use of pharmacometrics to optimize biosimilar development.
    Dodds M; Chow V; Markus R; Pérez-Ruixo JJ; Shen D; Gibbs M
    J Pharm Sci; 2013 Nov; 102(11):3908-14. PubMed ID: 24027111
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.
    Colbert A; Umble-Romero A; Prokop S; Chow VF; Wong T; DeSimone D; Zhou L; Pederson S
    MAbs; 2014; 6(5):1178-89. PubMed ID: 25517303
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study.
    Takács I; Jókai E; Kováts DE; Aradi I
    Osteoporos Int; 2019 Mar; 30(3):675-683. PubMed ID: 30357438
    [TBL] [Abstract][Full Text] [Related]  

  • 9. A note on sample size determination for bioequivalence studies with high-order crossover designs.
    Chen KW; Chow SC; Li G
    J Pharmacokinet Biopharm; 1997 Dec; 25(6):753-65. PubMed ID: 9697082
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Application of Pharmacometric Analysis in the Design of Clinical Pharmacology Studies for Biosimilar Development.
    Zhu P; Sy SKB; Skerjanec A
    AAPS J; 2018 Mar; 20(2):40. PubMed ID: 29516330
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Evolution of the EU Biosimilar Framework: Past and Future.
    Wolff-Holz E; Tiitso K; Vleminckx C; Weise M
    BioDrugs; 2019 Dec; 33(6):621-634. PubMed ID: 31541400
    [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. Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL-1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus.
    Heise T; Donnelly C; Barve A; Aubonnet P
    Diabetes Obes Metab; 2020 Apr; 22(4):521-529. PubMed ID: 31724253
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Comment on "Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?".
    Webster CJ; Woollett GR
    BioDrugs; 2019 Oct; 33(5):581-582. PubMed ID: 31372960
    [No Abstract]   [Full Text] [Related]  

  • 15. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira(®) in healthy subjects.
    Hyland E; Mant T; Vlachos P; Attkins N; Ullmann M; Roy S; Wagner V
    Br J Clin Pharmacol; 2016 Oct; 82(4):983-93. PubMed ID: 27285856
    [TBL] [Abstract][Full Text] [Related]  

  • 16. On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products.
    Chow SC; Song F; Cui C
    J Biopharm Stat; 2017; 27(2):265-271. PubMed ID: 28026996
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects.
    Wynne C; Altendorfer M; Sonderegger I; Gheyle L; Ellis-Pegler R; Buschke S; Lang B; Assudani D; Athalye S; Czeloth N
    Expert Opin Investig Drugs; 2016 Dec; 25(12):1361-1370. PubMed ID: 27813422
    [TBL] [Abstract][Full Text] [Related]  

  • 18. PF-06881893 (Nivestym™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen
    Yao HM; Ottery FD; Borema T; Harris S; Levy J; May TB; Moosavi S; Zhang J; Summers M
    BioDrugs; 2019 Apr; 33(2):207-220. PubMed ID: 30900158
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Comparative assessment of pharmacokinetics, and pharmacodynamics between RTXM83™, a rituximab biosimilar, and rituximab in diffuse large B-cell lymphoma patients: a population PK model approach.
    Candelaria M; Gonzalez D; Fernández Gómez FJ; Paravisini A; Del Campo García A; Pérez L; Miguel-Lillo B; Millán S
    Cancer Chemother Pharmacol; 2018 Mar; 81(3):515-527. PubMed ID: 29362903
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Simultaneous confidence interval methods for analytical similarity assessment.
    Zheng J; Yin D; Yuan M; Chow SC
    J Biopharm Stat; 2019; 29(5):920-940. PubMed ID: 31454290
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.