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FDA Guidance for Industry: Q1E Evaluation of Stability Data


ICH Secretariat c/o IFPMA, 30 rue de St - Jean, P.O. Box 9, 1211 Geneva 18, Switzerland ,

Document Type:
Guidance Document
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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