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Journal Abstract Search

204 related items for PubMed ID: 22877214

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

  • 4. Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management.
    Huang Y, Shi R, Gee W, Bonderud R.
    Bioanalysis; 2012 Aug; 4(15):1919-31. PubMed ID: 22943622
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  • 7. 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; 6(22):2957-63. PubMed ID: 25496252
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  • 8. Regulatory observations in bioanalytical determinations.
    Viswanathan CT.
    Bioanalysis; 2010 Jul; 2(7):1325-9. PubMed ID: 21083243
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  • 11. New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR.
    Zimmer D.
    Bioanalysis; 2014 Jan; 6(1):13-9. PubMed ID: 24256335
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  • 12. European Medicines Agency guideline on bioanalytical method validation: what more is there to say?
    Smith G.
    Bioanalysis; 2012 May; 4(8):865-8. PubMed ID: 22533559
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  • 13. 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
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  • 14. Validation of analytical methods-update 2011.
    Indrayanto G.
    Profiles Drug Subst Excip Relat Methodol; 2012 Apr; 37():439-65. PubMed ID: 22469326
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  • 15. 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
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  • 16. 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 15; 2(4):683. PubMed ID: 21083261
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  • 17. Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation.
    Smith G.
    Bioanalysis; 2009 Aug 15; 1(5):877-81. PubMed ID: 21083057
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  • 18. Comparison of various international guidelines for analytical method validation.
    Chandran S, Singh RS.
    Pharmazie; 2007 Jan 15; 62(1):4-14. PubMed ID: 17294806
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  • 19. Capsule review on bioanalytical method transfer: opportunities and challenges for chromatographic methods.
    Lin ZJ, Li W, Weng N.
    Bioanalysis; 2011 Jan 15; 3(1):57-66. PubMed ID: 21175367
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  • 20. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
    Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, Fang X.
    Bioanalysis; 2012 Mar 15; 4(6):651-60. PubMed ID: 22452256
    [No Abstract] [Full Text] [Related]

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