FDA Guidance for Industry: Q1B Photostability Testing of New Drug Substances and Products
Title:
FDA Guidance for Industry: Q1B Photostability 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/ucm073373.pdf
Document Type:
FDA Guidance for Industry
Content:
This ICH guideline gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.