FDA Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology
Title:
FDA Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology
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 ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073384.pdf
Document Type:
FDA Guidance for Industry
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.