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 *

158 related articles for article (PubMed ID: 36529216)

  • 1. Taking the individual bias out of examining comparability of biosimilars: A case study on monoclonal antibody therapeutics.
    Rathore AS; Joshi S; Nupur N; Saxena N; Bhattacharya S; Roy S
    Int J Biol Macromol; 2023 Feb; 227():124-133. PubMed ID: 36529216
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. 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]  

  • 4. Multi-attribute method (MAM) to assess analytical comparability of adalimumab biosimilars.
    Millán-Martín S; Jakes C; Carillo S; Bones J
    J Pharm Biomed Anal; 2023 Sep; 234():115543. PubMed ID: 37385093
    [TBL] [Abstract][Full Text] [Related]  

  • 5. NMR based quality evaluation of mAb therapeutics: A proof of concept higher order structure biosimilarity assessment of trastuzumab biosimilars.
    Joshi S; Khatri LR; Kumar A; Rathore AS
    J Pharm Biomed Anal; 2022 May; 214():114710. PubMed ID: 35290923
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review.
    Alsamil AM; Giezen TJ; Egberts TC; Leufkens HG; Vulto AG; van der Plas MR; Gardarsdottir H
    Eur J Pharm Sci; 2020 Nov; 154():105501. PubMed ID: 32739253
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies.
    Ishii-Watabe A; Kuwabara T
    Drug Metab Pharmacokinet; 2019 Feb; 34(1):64-70. PubMed ID: 30600193
    [TBL] [Abstract][Full Text] [Related]  

  • 8. A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies.
    Guillen E; Ekman N; Barry S; Weise M; Wolff-Holz E
    Clin Pharmacol Ther; 2023 Jan; 113(1):108-123. PubMed ID: 36546547
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars.
    Vandekerckhove K; Seidl A; Gutka H; Kumar M; Gratzl G; Keire D; Coffey T; Kuehne H
    AAPS J; 2018 May; 20(4):68. PubMed ID: 29748754
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. 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]  

  • 12. Need for a risk-based control strategy for managing glycosylation profile for biosimilar products.
    Rathore A; Malani H
    Expert Opin Biol Ther; 2022 Feb; 22(2):123-131. PubMed ID: 34431439
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Demonstration of biosimilarity, extrapolation of indications and other challenges related to biosimilars in Europe.
    Tsiftsoglou AS; Trouvin JH; Calvo G; Ruiz S
    BioDrugs; 2014 Dec; 28(6):479-86. PubMed ID: 25391420
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Assessing analytical comparability of biosimilars: GCSF as a case study.
    Nupur N; Singh SK; Narula G; Rathore AS
    J Chromatogr B Analyt Technol Biomed Life Sci; 2016 Oct; 1032():165-171. PubMed ID: 27289250
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [Biosimilars in the European Union: current situation and challenges].
    Wolff-Holz E; Weise M
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2020 Nov; 63(11):1365-1372. PubMed ID: 33034693
    [TBL] [Abstract][Full Text] [Related]  

  • 16. How Similar Is Biosimilar? A Comparison of Infliximab Therapeutics in Regard to Charge Variant Profile and Antigen Binding Affinity.
    Beyer B; Walch N; Jungbauer A; Lingg N
    Biotechnol J; 2019 Apr; 14(4):e1800340. PubMed ID: 30315690
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Cation exchange chromatography on a monodisperse 3 µm particle enables extensive analytical similarity assessment of biosimilars.
    Füssl F; Millán-Martín S; Bones J; Carillo S
    J Pharm Biomed Anal; 2023 Sep; 234():115534. PubMed ID: 37343453
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Assessment of structural and functional similarity of biosimilar products: Bevacizumab as a case study.
    Bhattacharya S; Rathore AS
    J Chromatogr B Analyt Technol Biomed Life Sci; 2023 Sep; 1229():123896. PubMed ID: 37776677
    [TBL] [Abstract][Full Text] [Related]  

  • 20. 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]  

    [Next]    [New Search]
    of 8.