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FDA Guidance for Industry: Q1E Evaluation of Stability Data
Origin/Publisher:
ICH Secretariat c/o IFPMA, 30 rue de St - Jean, P.O. Box 9, 1211 Geneva 18, Switzerland http://www.ich.org , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073380.pdf
Document Type:
Guidance Document
Content:
This guideline is intended to address recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline Q1A(R) to propose a shelf life.
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