The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Q1E Evaluation of Stability Data


ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland;

Document Type:
ICH Guideline
This guidelines is intended to address recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline Q1A(R2) to propose a retest period or shelf life.

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