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Journal Abstract Search

373 related items for PubMed ID: 21083120

  • 1. 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
    [Abstract] [Full Text] [Related]

  • 2. 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
    [Abstract] [Full Text] [Related]

  • 3. 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
    Garofolo F, Rocci ML, Dumont I, Martinez S, Lowes S, Woolf E, van Amsterdam P, Bansal S, Barra AC, Bauer R, Booth BP, Carrasco-Triguero M, DeSilva B, Dunn J, Gallicano K, Gouty D, Ho S, Hucker R, Jemal M, Katori N, Le Blaye O, Lee J, Li W, Michael S, Nehls C, Nicholson R, Ormsby E, Tang D, Viswanathan CT, Weiner R, Young G.
    Bioanalysis; 2011 Sep; 3(18):2081-96. PubMed ID: 21942519
    [Abstract] [Full Text] [Related]

  • 4. The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.
    Savoie N, Booth BP, Bradley T, Garofolo F, Hughes NC, Hussain S, King SP, Lindsay M, Lowes S, Ormsby E, Phull R, Rocci ML, Vallano PT, Viau A, Zhu Z.
    Bioanalysis; 2009 Apr; 1(1):19-30. PubMed ID: 21083184
    [Abstract] [Full Text] [Related]

  • 5. 2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.
    Stevenson L, Garofolo F, DeSilva B, Dumont I, Martinez S, Rocci M, Amaravadi L, Brudny-Kloeppel M, Musuku A, Booth B, Dicaire C, Wright L, Mayrand-Provencher L, Losauro M, Gouty D, Arnold M, Bansal S, Dudal S, Dufield D, Duggan J, Evans C, Fluhler E, Fraser S, Gorovits B, Haidar S, Hayes R, Ho S, Houghton R, Islam R, Jenkins R, Katori N, Kaur S, Kelley M, Knutsson M, Lee J, Liu H, Lowes S, Ma M, Mikulskis A, Myler H, Nicholson B, Olah T, Ormsby E, Patel S, Pucci V, Ray C, Schultz G, Shih J, Shoup R, Simon C, Song A, Neto JT, Theobald V, Thway T, Wakelin-Smith J, Wang J, Wang L, Welink J, Whale E, Woolf E, Xu R.
    Bioanalysis; 2013 Dec; 5(23):2903-18. PubMed ID: 24107004
    [Abstract] [Full Text] [Related]

  • 6. 2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
    DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, Yang E.
    Bioanalysis; 2012 Sep; 4(18):2213-26. PubMed ID: 23046264
    [Abstract] [Full Text] [Related]

  • 7. 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]

  • 8. Key elements of bioanalytical method validation for small molecules.
    Bansal S, DeStefano A.
    AAPS J; 2007 Mar 30; 9(1):E109-14. PubMed ID: 17408234
    [Abstract] [Full Text] [Related]

  • 9. Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management.
    Huang Y, Shi R, Gee W, Bonderud R.
    Bioanalysis; 2012 Aug 30; 4(15):1919-31. PubMed ID: 22943622
    [Abstract] [Full Text] [Related]

  • 10. Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation.
    Smith G.
    Bioanalysis; 2009 Aug 30; 1(5):877-81. PubMed ID: 21083057
    [No Abstract] [Full Text] [Related]

  • 11. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
    Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F, Alley SC, Thway T, Joyce A, Bansal S, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Dumont I, Fluhler E, Fraser S, Gouty D, Gupta S, Haidar S, Hayes R, Ingelse B, Ishii-Watabe A, Kaur S, King L, Laterza O, Leung S, Lévesque A, Ma M, Petit-Frere C, Pillutla R, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wakelin-Smith J, Wilson A, Woolf E, Yang TY.
    Bioanalysis; 2014 Aug 30; 6(24):3355-68. PubMed ID: 25534792
    [Abstract] [Full Text] [Related]

  • 12. Regulatory observations in bioanalytical determinations.
    Viswanathan CT.
    Bioanalysis; 2010 Jul 30; 2(7):1325-9. PubMed ID: 21083243
    [Abstract] [Full Text] [Related]

  • 13. Aspects of bioanalytical method validation for the quantitative determination of trace elements.
    Levine KE, Tudan C, Grohse PM, Weber FX, Levine MA, Kim YS.
    Bioanalysis; 2011 Aug 30; 3(15):1699-712. PubMed ID: 21827269
    [Abstract] [Full Text] [Related]

  • 14.
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    [No Abstract] [Full Text] [Related]

  • 15. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).
    Dufield D, Neubert H, Garofolo F, Kirkovsky L, Stevenson L, Dumont I, Kaur S, Xu K, Alley SC, Szapacs M, Arnold M, Bansal S, Haidar S, Welink J, Le Blaye O, Wakelin-Smith J, Whale E, Ishii-Watabe A, Bustard M, Katori N, Amaravadi L, Aubry AF, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Duggan J, Fluhler E, Gorovits B, Gupta S, Hayes R, Ho S, Ingelse B, King L, Lévesque A, Lowes S, Ma M, Musuku A, Myler H, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wilson A, Woolf E, Xue L, Yang TY.
    Bioanalysis; 2014 Aug 30; 6(23):3237-49. PubMed ID: 25529890
    [Abstract] [Full Text] [Related]

  • 16. Comparison of various international guidelines for analytical method validation.
    Chandran S, Singh RS.
    Pharmazie; 2007 Jan 30; 62(1):4-14. PubMed ID: 17294806
    [Abstract] [Full Text] [Related]

  • 17. 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 30; 2(4):683. PubMed ID: 21083261
    [No Abstract] [Full Text] [Related]

  • 18. Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis.
    Freisleben A, Brudny-Klöppel M, Mulder H, de Vries R, de Zwart M, Timmerman P.
    Bioanalysis; 2011 Jun 30; 3(12):1333-6. PubMed ID: 21679027
    [Abstract] [Full Text] [Related]

  • 19. Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.
    Kadian N, Raju KS, Rashid M, Malik MY, Taneja I, Wahajuddin M.
    J Pharm Biomed Anal; 2016 Jul 15; 126():83-97. PubMed ID: 27179186
    [Abstract] [Full Text] [Related]

  • 20. Advances in validation, risk and uncertainty assessment of bioanalytical methods.
    Rozet E, Marini RD, Ziemons E, Boulanger B, Hubert P.
    J Pharm Biomed Anal; 2011 Jun 25; 55(4):848-58. PubMed ID: 21237607
    [Abstract] [Full Text] [Related]

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