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Bioanalytical Method Validation: Notable Points in The 2009 Draft EMA Guideline and Differences with The 2001 FDA Guidance

Method ValidationFda GuidancePreclinical Drug EvaluationMedicineBioanalysisEvidence-based MedicineBiostatisticsVerification And ValidationClinical ChemistryBioanalytical Method ValidationDrug TrialLaboratory MedicineDraft Ema Guideline