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Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Pharmaceutical Research · 2006 · Vol. 23(2) · pp. 312–328
Jean W. LeeViswanath DevanarayanYu Chen BarrettRussell WeinerJohn AllinsonScott FountainStephen KellerIra WeinrybMarie GreenLarry DuanJames A. RogersRobert MillhamPeter J. O’BrienJeff M. SailstadMasood N. KhanChad RayJohn A. Wagner
Biosimilars and Bioanalytical MethodsStatistical Methods in Clinical TrialsComputational Drug Discovery MethodsBiomarkerDrug developmentContext (archaeology)Biomarker discoveryPaceComputer scienceMedicineRisk analysis (engineering)Data scienceMedical physics

MeSH terms

CalibrationData Interpretation, StatisticalTerminology as TopicQuality ControlDrug DesignReproducibility of ResultsModels, StatisticalBiomarkers
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