Q1E Evaluation of Stability Data

Title:
Q1E Evaluation of Stability Data

https://www.gmp-compliance.org/files/guidemgr/Q1Estep4.pdf

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 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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