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 *

152 related articles for article (PubMed ID: 30994006)

  • 1. Regulatory perspective of biomarker bioanalysis during drug development.
    Yu C; Bashaw ED
    Bioanalysis; 2019 Apr; 11(7):607-610. PubMed ID: 30994006
    [No Abstract]   [Full Text] [Related]  

  • 2. 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (
    Booth B; Stevenson L; Pillutla R; Buonarati M; Beaver C; Fraier D; Garofolo F; Haidar S; Islam R; James C; Kadavil J; Kavetska O; Li F; Satterwhite C; Savoie N; Subramaniam S; Tampal N; Thway T; Woolf E; Blaye OL; Andisik M; Briscoe C; Cape S; Dasgupta A; Fischer S; Haidar S; Hayes R; Kamerud J; Lima Santos GM; Nehls C; Soo C; Vinter S; Whale E; Xu K; Cho SJ; Edmison A; Kassim S; Rocha TC; Welink J; Amur S; Bandukwala A; Cherry E; Hopper S; Ishii-Watabe A; Kirshner S; Maher K; Pedras-Vasconcelos J; Saito Y; Saunders TS; Skibeli V; Verthelyi D; Wang YM; Yan H
    Bioanalysis; 2019 Dec; 11(23):2099-2132. PubMed ID: 31833782
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Ask the experts: method transfer.
    James CA; Cheah TC; Perkins J; Allinson JL
    Bioanalysis; 2015; 7(7):789-93. PubMed ID: 25932512
    [TBL] [Abstract][Full Text] [Related]  

  • 4. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers.
    Lowes S; Ackermann BL
    Bioanalysis; 2016 Feb; 8(3):163-7. PubMed ID: 26795584
    [TBL] [Abstract][Full Text] [Related]  

  • 5. The Waters Bioanalysis World Tour: insights into the next decade of regulated bioanalysis.
    De Vooght-Johnson R
    Bioanalysis; 2011 Feb; 3(4):369-82. PubMed ID: 21247354
    [No Abstract]   [Full Text] [Related]  

  • 6. The FDA/critical path initiative/Duke-Margolis center for health policy public workshop on analytical validation of assays for biomarker qualification: an update on the White Paper.
    Piccoli SP
    Bioanalysis; 2018 Jun; 10(12):893-896. PubMed ID: 29924636
    [No Abstract]   [Full Text] [Related]  

  • 7. Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum.
    Kall MA; Michi M; van der Strate B; Freisleben A; Stoellner D; Timmerman P
    Bioanalysis; 2018 Nov; 10(21):1723-1732. PubMed ID: 30412676
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Clinical and pharmaceutical success from discovery to regulatory approval: biomarkers, modeling and analytical technologies.
    Zhang TT; Weng N; Lee M
    Bioanalysis; 2017 Oct; 9(19):1437-1440. PubMed ID: 29057664
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Japanese bioanalytical method validation guideline: the world's first regulatory guideline dedicated to ligand-binding assays.
    Imazato-Hirano M; Taniguchi Y; Kakehi M; Kuze Y; Nakamura T; Minamide Y; Miya K; Hosogi J; Katashima M; Maekawa K; Okuda H; Niimi S; Kawasaki N; Ishii-Watabe A; Katori N
    Bioanalysis; 2015; 7(9):1151-6. PubMed ID: 26039811
    [No Abstract]   [Full Text] [Related]  

  • 10. Biomarker assay validation.
    Piccoli SP; Garofolo F
    Bioanalysis; 2018 Jun; 10(12):889-891. PubMed ID: 29939799
    [No Abstract]   [Full Text] [Related]  

  • 11. Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.
    Timmerman P; Scheel Fjording M; Allinson J; Arfvidsson C; Barroso B; Diczfalusy U; Freeman A; Hickford E; Kandousi H; Katugampola S; Kunz U; Nelson R; Smeraglia J
    Bioanalysis; 2017 May; 9(9):675-681. PubMed ID: 28520459
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective.
    Cowan KJ
    Bioanalysis; 2016 Jun; 8(12):1221-3. PubMed ID: 27149903
    [No Abstract]   [Full Text] [Related]  

  • 13. A look back at the incurred sample reanalysis.
    Vazvaei F
    Bioanalysis; 2018 Nov; 10(21):1711-1713. PubMed ID: 30412679
    [No Abstract]   [Full Text] [Related]  

  • 14. 8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
    Bower J; Fast D; Garofolo F; Gouty D; Hayes R; Lowes S; Nicholson R; LeLacheur R; Bravo J; Shoup R; Dumont I; Carbone M; Zimmer J; Ortuno J; Caturla MC; Datin J; Lansing T; Fatmi S; Struwe P; Sheldon C; Islam R; Yu M; Hulse J; Kamerud J; Lin J; Doughty J; Kurylak K; Tang D; Buonarati M; Blanchette A; Levesque A; Gagnon-Carignan S; Lin J; Ray G; Liu Y; Khan M; Xu A; El-Sulayman G; DiMarco C; Bouhajib M; Tacey D; Jenkins R; der Strate Bv; Briscoe C; Karnik S; Rhyne P; Garofolo W; Schultz G; Roberts A; Redrup M; DuBey I; Conliffe P; Pekol T; Hantash J; Cojocaru L; Allen M; Reuschel S; Watson A; Farrell C; Groeber E; Malone M; Nowatzke W; Fang X
    Bioanalysis; 2014; 6(22):2957-63. PubMed ID: 25496252
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.
    Watson RG; Clements-Egan A; Schantz A; Ware M; Wu B; Yang TY; Shankar G; Marini JC
    Bioanalysis; 2017 Sep; 9(18):1407-1422. PubMed ID: 28920457
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Biomarkers as drug development tools: discovery, validation, qualification and use.
    Kraus VB
    Nat Rev Rheumatol; 2018 Jun; 14(6):354-362. PubMed ID: 29760435
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Bioanalytical Procedures and Regulation: Towards Global Harmonization.
    Hill HM
    Bioanalysis; 2011 Feb; 3(4):365-7. PubMed ID: 21338256
    [No Abstract]   [Full Text] [Related]  

  • 18. Measurement of mRNA therapeutics: method development and validation challenges.
    Henderson N; Wilson A
    Bioanalysis; 2019 Nov; 11(21):2003-2010. PubMed ID: 31657232
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The ninth Japan Bioanalysis Forum symposium.
    Komaba J; Hosogi J; Igarashi H; Kamimori H; Nakai K; Nakamura T; Kawai Y; Sano Y; Yamaguchi T
    Bioanalysis; 2018 Sep; 10(18):1467-1471. PubMed ID: 30198754
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Building a roadmap to biomarker qualification: challenges and opportunities.
    Amur SG; Sanyal S; Chakravarty AG; Noone MH; Kaiser J; McCune S; Buckman-Garner SY
    Biomark Med; 2015; 9(11):1095-105. PubMed ID: 26526897
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.