FDA Guidance for Industry: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Title:
FDA Guidance for Industry: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
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/ucm073379.pdf
Document Type:
FDA Guidance for Industry
Content:
This guidelines is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH guideline Q1A(R).