Guideline

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Q2B Validation of Analytical Procedures: Methodology
Short Title:	Q2B
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073384.pdf
Origin/Publisher:	Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:	This Guideline extends the guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures.
Document Type:	FDA Guidance for Industry