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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.
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| Q1E Evaluation of Stability Data |
| Short Title: | Q1E |
| Internet: | http://www.fda.gov/cder/guidance/5531fnl.pdf |
| Origin/Publisher: | ICH Secretariat c/o IFPMA, 30 rue de St - Jean, P.O. Box 9, 1211 Geneva 18, Switzerland http://www.ich.org |
| 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. |
| Status: | finalised document |
| Document Type: | Guidance Document |
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