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Journal Abstract Search

180 related items for PubMed ID: 21083486

  • 1.
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  • 2. Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.
    Timmerman P, Lowes S, Fast DM, Garofolo F.
    Bioanalysis; 2010 Apr; 2(4):683. PubMed ID: 21083261
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  • 4. Formation of a Global Contract Research Organization Council for Bioanalysis.
    Premkumar N, Lowes S, Jersey J, Garofolo F, Dumont I, Masse R, Stamatiou B, Caturla MC, Steffen R, Malone M, Offman E, Samuels T, Oldfield P, Di Donato L, Fast D, Tang D, Moussallie M, Doughty J, Rocci M, Buonarati M, Gouty D, Dadgar D, Stamatopoulos J, Breau A, Ntsikoussalabongui B, Bouhajib M, Nicholson B, Tacey R, Ketelaar P, Briscoe C, Karnik S, Wieling J, Smith JK, Reid MJ, Lelacheur R, Chapdelaine J, Fatmi S, Sayyarpour F, Fang X, Cook J, Browne D.
    Bioanalysis; 2010 Nov; 2(11):1797-800. PubMed ID: 21083485
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  • 5. Towards harmonized regulations for bioanalysis: moving forward!
    van Amsterdam P, Lausecker B, Luedtke S, Timmerman P, Brudny-Kloeppel M.
    Bioanalysis; 2010 Apr; 2(4):689-91. PubMed ID: 21083263
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  • 6. 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.
    Savoie N, Garofolo F, van Amsterdam P, Booth BP, Fast DM, Lindsay M, Lowes S, Masse R, Mawer L, Ormsby E, Phull R, Rocci ML, Vallano PT, Yin X.
    Bioanalysis; 2010 Jan; 2(1):53-68. PubMed ID: 21083120
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  • 9. Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation.
    Smith G.
    Bioanalysis; 2009 Aug; 1(5):877-81. PubMed ID: 21083057
    [No Abstract] [Full Text] [Related]

  • 10. Repeat analysis and incurred sample reanalysis: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.
    Fluhler E, Vazvaei F, Singhal P, Vinck P, Li W, Bhatt J, de Boer T, Chaudhary A, Tangiuchi M, Rezende V, Zhong D.
    AAPS J; 2014 Nov; 16(6):1167-74. PubMed ID: 25135836
    [Abstract] [Full Text] [Related]

  • 11. Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).
    Sangster T, Maltas J, Struwe P, Hillier J, Boterman M, Doig M, Breda M, Garofolo F, Caturla MC, Couerbe P, Schiebl C, Pattison C, Goodwin L, Segers R, Garofolo W, Folguera L, Zimmer D, Zimmerman T, Pawula M, Tang D, Cox C, Bigogno C, Schoutsen D, de Boer T, Green R, Houghton R, Sable R, Siethoff C, Harter T, Best S, Global CRO Council for Bioanalysis (GCC).
    Bioanalysis; 2012 Jul; 4(14):1723-30. PubMed ID: 22877218
    [No Abstract] [Full Text] [Related]

  • 12. Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?
    Kaza M, Karaźniewicz-Łada M, Kosicka K, Siemiątkowska A, Rudzki PJ.
    J Pharm Biomed Anal; 2019 Feb 20; 165():381-385. PubMed ID: 30590335
    [Abstract] [Full Text] [Related]

  • 13. European Medicines Agency guideline on bioanalytical method validation: what more is there to say?
    Smith G.
    Bioanalysis; 2012 May 20; 4(8):865-8. PubMed ID: 22533559
    [No Abstract] [Full Text] [Related]

  • 14. Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance.
    Smith G.
    Bioanalysis; 2010 May 20; 2(5):929-35. PubMed ID: 21083222
    [No Abstract] [Full Text] [Related]

  • 15. Comparison of various international guidelines for analytical method validation.
    Chandran S, Singh RS.
    Pharmazie; 2007 Jan 20; 62(1):4-14. PubMed ID: 17294806
    [Abstract] [Full Text] [Related]

  • 16. Key aspects of analytical method validation and linearity evaluation.
    Araujo P.
    J Chromatogr B Analyt Technol Biomed Life Sci; 2009 Aug 01; 877(23):2224-34. PubMed ID: 18929516
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  • 17. How to manage having no incurred sample reanalysis evaluation failures.
    Garofolo F, Bergeron A, Savoie N.
    Bioanalysis; 2011 May 01; 3(9):935-8. PubMed ID: 21545339
    [No Abstract] [Full Text] [Related]

  • 18. A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation.
    Boulanger B, Rozet E, Moonen F, Rudaz S, Hubert P.
    J Chromatogr B Analyt Technol Biomed Life Sci; 2009 Aug 01; 877(23):2235-43. PubMed ID: 19577965
    [Abstract] [Full Text] [Related]

  • 19. 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 Aug 01; 6(22):2957-63. PubMed ID: 25496252
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  • 20. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.
    Lowes S, Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, Fang X.
    Bioanalysis; 2012 Apr 01; 4(7):763-8. PubMed ID: 22512795
    [Abstract] [Full Text] [Related]

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