BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

192 related articles for article (PubMed ID: 21756087)

  • 1. Differences in bioanalytical method validation for biologically derived macromolecules (biosimilars) compared with small molecules (generics).
    Oldfield P
    Bioanalysis; 2011 Jul; 3(14):1551-3. PubMed ID: 21756087
    [No Abstract]   [Full Text] [Related]  

  • 2. Key elements of bioanalytical method validation for small molecules.
    Bansal S; DeStefano A
    AAPS J; 2007 Mar; 9(1):E109-14. PubMed ID: 17408234
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
    Savoie N; Garofolo F; van Amsterdam P; Bansal S; Beaver C; Bedford P; Booth BP; Evans C; Jemal M; Lefebvre M; Lopes de Silva AL; Lowes S; Marini JC; Massé R; Mawer L; Ormsby E; Rocci ML; Viswanathan C; Wakelin-Smith J; Welink J; White JT; Woolf E
    Bioanalysis; 2010 Dec; 2(12):1945-60. PubMed ID: 21110739
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Introduction to calibration curves in bioanalysis.
    Brewer E; Bollin E
    Bioanalysis; 2009 Oct; 1(7):1201-8. PubMed ID: 21083046
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Bioanalytical challenges of biosimilars.
    Islam R
    Bioanalysis; 2014 Feb; 6(3):349-56. PubMed ID: 24471955
    [TBL] [Abstract][Full Text] [Related]  

  • 6. A wide angle view of biosimilars from a bioanalytical perspective.
    Oldfield P
    Bioanalysis; 2013 Mar; 5(5):533-5. PubMed ID: 23425269
    [No Abstract]   [Full Text] [Related]  

  • 7. Regulated bioanalysis: an Indian perspective on harmonization efforts.
    Ramanathan VK; Vachharajani NN
    Bioanalysis; 2011 Apr; 3(7):713-6. PubMed ID: 21452987
    [No Abstract]   [Full Text] [Related]  

  • 8. Analysis of biological therapeutic agents and biosimilars.
    Phinney K
    Anal Bioanal Chem; 2014 Oct; 406(26):6539. PubMed ID: 25190012
    [No Abstract]   [Full Text] [Related]  

  • 9. Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
    Cai XY; Wake A; Gouty D
    Bioanalysis; 2013 Mar; 5(5):517-20. PubMed ID: 23425265
    [No Abstract]   [Full Text] [Related]  

  • 10. Challenges in bioanalytical assays for biosimilars.
    Wang X; Chen L
    Bioanalysis; 2014 Aug; 6(16):2111-3. PubMed ID: 25331854
    [No Abstract]   [Full Text] [Related]  

  • 11. Uncertainty profiles for the validation of analytical methods.
    Saffaj T; Ihssane B
    Talanta; 2011 Sep; 85(3):1535-42. PubMed ID: 21807219
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
    Lowes S; Jersey J; Shoup R; Garofolo F; Savoie N; Mortz E; Needham S; Caturla MC; Steffen R; Sheldon C; Hayes R; Samuels T; Di Donato L; Kamerud J; Michael S; Lin ZJ; Hillier J; Moussallie M; de Souza Teixeira L; Rocci M; Buonarati M; Truog J; Hussain S; Lundberg R; Breau A; Zhang T; Jonker J; Berger N; Gagnon-Carignan S; Nehls C; Nicholson R; Hilhorst M; Karnik S; de Boer T; Houghton R; Smith K; Cojocaru L; Allen M; Harter T; Fatmi S; Sayyarpour F; Vija J; Malone M; Heller D
    Bioanalysis; 2011 Jun; 3(12):1323-32. PubMed ID: 21679026
    [TBL] [Abstract][Full Text] [Related]  

  • 13. European perspective on biosimilars.
    Wadhwa M; Thorpe R
    Bioanalysis; 2013 Mar; 5(5):521-4. PubMed ID: 23425266
    [No Abstract]   [Full Text] [Related]  

  • 14. Conference Report: Bioanalysis-related topics presented at the International Conference and Exhibition on Biowaivers and Biosimilars.
    Colletti KS
    Bioanalysis; 2013 Mar; 5(5):529-31. PubMed ID: 23425268
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Biosimilars: where we were and where we are.
    Challand R; Gorham H; Constant J
    J Biopharm Stat; 2014; 24(6):1154-64. PubMed ID: 25036475
    [TBL] [Abstract][Full Text] [Related]  

  • 16. How can chromatographic baseline integration parameters be objectively established in the bioanalytical laboratory?
    James CA; Bruenner BA; Wong P
    Bioanalysis; 2015; 7(8):931-3. PubMed ID: 25966005
    [No Abstract]   [Full Text] [Related]  

  • 17. [When two do the same, it is not the same. Requirements for development and quality of biosimilars].
    Rais I
    Pharm Unserer Zeit; 2012 Nov; 41(6):453-60. PubMed ID: 23362548
    [No Abstract]   [Full Text] [Related]  

  • 18. Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
    Nicholson R; Lowes S; Caturla MC; Safavi A; Mamelak D; Islam R; Allinson J; Gouty D; Khan M; Lelacheur R; Shoup R; Martinez S; Dumont I; Zimmer J; Steffen R; Petrilla J; Awaiye K; Sheldon C; Turk D; Fast D; Kamerud J; Dinan A; Lin ZJ; Garofolo W; Tang D; Wright L; Lin J; Yamashita Y; Liu Y; Xu A; Hayes R; Bouhajib M; Levesque A; Gagnon-Carignan S; Harman J; Warren M; Karnik S; Cojocaru L; Reuschel S; Gonzalez P; Fatmi S; Vija J; Rock M; Malone M; Nowatzke W; Fang X
    Bioanalysis; 2012 Oct; 4(19):2335-42. PubMed ID: 23088460
    [No Abstract]   [Full Text] [Related]  

  • 19. Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development.
    Obianom ON; Thway TM; Schrieber SJ; Okusanya OO; Wang YM; Huang SM; Zineh I
    AAPS J; 2019 Sep; 21(6):105. PubMed ID: 31512109
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Nonclinical development of a biosimilar: the current landscape.
    O'Connor A; Rogge M
    Bioanalysis; 2013 Mar; 5(5):537-44. PubMed ID: 23425270
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.