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.
ICH Q1E Evaluation for Stability Data
Origin/Publisher:
ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland; http://www.ich.org
Document Type:
ICH Guideline
Content:
This guidelines is intended to provide recommendations on how to use stability data to propose a retest period or shelf life in a registration application.
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