Incurred sample reanalysis in AstraZeneca small molecule portfolio - what have we learned and where do we go next?

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作者： Cecilia,Arfvidsson ^[1] ; Amanda,Wilson ^[2] ; Maria,Heijer ^[1] ; Christopher,Bailey ^[3] ; Paul,Severin ^[4] ; Fiona,Milligan ^[5] ; Maryann,Ngeny ^[6] ; Brian,Dayton ^[4] ; Yan,Li ^[7] ; Stephanie,Cape ^[4]

作者单位： Clinical Sample & Bioanalytical Science, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, 431 83 Mölndal, Sweden. ^[1] Translational Bioanalysis & Biomarkers, Drug Safety & Metabolism, IMED Biotech Unit, AstraZeneca, Cambridge, CB4OWG, UK. ^[2] Clinical Sample & Bioanalytical Science, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, CB4OWG, UK. ^[3] Bioanalytical Chemistry, Covance Laboratories, Madison, WI 53704, USA. ^[4] Charles River Laboratories Edinburgh Ltd, Tranent, Edinburgh, EH332NE, UK. ^[5] Early Product Development, Pharmaceutical Sciences, IMED Biotech Unit, AstraZeneca, Macclesfield, SK10ZNA, UK. ^[6] Clinical Sample & Bioanalytical Science, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Boston, 02451 MA, USA. ^[7]

关键词 capillary plasma microsampling clinical bioanalysis incurred sample reanalysis incurred sample reproducibility pharmacokinetics ?bioanalytical method validation