BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

201 related articles for article (PubMed ID: 27709452)

  • 1. Statistical Approaches to Assess Biosimilarity from Analytical Data.
    Burdick R; Coffey T; Gutka H; Gratzl G; Conlon HD; Huang CT; Boyne M; Kuehne H
    AAPS J; 2017 Jan; 19(1):4-14. PubMed ID: 27709452
    [TBL] [Abstract][Full Text] [Related]  

  • 2. On the establishment of equivalence acceptance criterion in analytical similarity assessment.
    Wang T; Chow SC
    J Biopharm Stat; 2017; 27(2):206-212. PubMed ID: 28051920
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Analytical Similarity Assessment in Biosimilar Studies.
    Chow SC; Song F; Bai H
    AAPS J; 2016 May; 18(3):670-7. PubMed ID: 26873509
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal.
    Mielke J; Innerbichler F; Schiestl M; Ballarini NM; Jones B
    AAPS J; 2018 Nov; 21(1):7. PubMed ID: 30483892
    [TBL] [Abstract][Full Text] [Related]  

  • 5. On Statistical Approaches for Demonstrating Analytical Similarity in the Presence of Correlation.
    Yang H; Novick S; Burdick RK
    PDA J Pharm Sci Technol; 2016 11/12; 70(6):547-559. PubMed ID: 27325594
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Development of biosimilars.
    Al-Sabbagh A; Olech E; McClellan JE; Kirchhoff CF
    Semin Arthritis Rheum; 2016 Apr; 45(5 Suppl):S11-8. PubMed ID: 26947440
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Considerations of critical quality attributes in the analytical comparability assessment of biosimilar products.
    Kwon O; Joung J; Park Y; Kim CW; Hong SH
    Biologicals; 2017 Jul; 48():101-108. PubMed ID: 28495312
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The process defines the product: what really matters in biosimilar design and production?
    Vulto AG; Jaquez OA
    Rheumatology (Oxford); 2017 Aug; 56(suppl_4):iv14-iv29. PubMed ID: 28903544
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. Sample size requirement in analytical studies for similarity assessment.
    Chow SC; Song F; Bai H
    J Biopharm Stat; 2017; 27(2):233-238. PubMed ID: 27935446
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Differentiating biosimilarity and comparability in biotherapeutics.
    Azevedo V; Hassett B; Fonseca JE; Atsumi T; Coindreau J; Jacobs I; Mahgoub E; O'Brien J; Singh E; Vicik S; Fitzpatrick B
    Clin Rheumatol; 2016 Dec; 35(12):2877-2886. PubMed ID: 27734233
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses.
    Lee J; Kang HA; Bae JS; Kim KD; Lee KH; Lim KJ; Choo MJ; Chang SJ
    MAbs; 2018; 10(4):547-571. PubMed ID: 29482416
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
    Alvarez DF; Wolbink G; Cronenberger C; Orazem J; Kay J
    BioDrugs; 2020 Dec; 34(6):723-732. PubMed ID: 32990892
    [TBL] [Abstract][Full Text] [Related]  

  • 14. An evaluation roadmap for critical quality attributes from tier 1 in analytical similarity assessment.
    Wu K; Pan H; Li C; Zhao Q; Wang L; Xia J
    PLoS One; 2018; 13(12):e0208354. PubMed ID: 30521581
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Statistical considerations regarding correlated lots in analytical biosimilar equivalence test.
    Shen M; Wang T; Tsong Y
    J Biopharm Stat; 2017; 27(2):213-219. PubMed ID: 27906604
    [TBL] [Abstract][Full Text] [Related]  

  • 16. QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®.
    Jaffar-Aghaei M; Khanipour F; Maghsoudi A; Sarvestani R; Mohammadian M; Maleki M; Havasi F; Rahmani H; Karagah AH; Kazemali MR
    Eur J Pharm Sci; 2022 Jun; 173():106171. PubMed ID: 35378209
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Comparability of critical quality attributes for establishing biosimilarity.
    Liao JJ; Darken PF
    Stat Med; 2013 Feb; 32(3):462-9. PubMed ID: 22903263
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.
    Nupur N; Joshi S; Gulliarme D; Rathore AS
    Front Bioeng Biotechnol; 2022; 10():832059. PubMed ID: 35223794
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Development of statistical methods for analytical similarity assessment.
    Tsong Y; Dong X; Shen M
    J Biopharm Stat; 2017; 27(2):197-205. PubMed ID: 27977326
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Comments on the FDA draft guidance on biosimilar products.
    Chow SC; Endrenyi L; Lachenbruch PA
    Stat Med; 2013 Feb; 32(3):364-9. PubMed ID: 22903309
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.