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Guideline

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.

Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
Short Title:Q1A(R2)
Internet:http://private.ich.org/LOB/media/MEDIA419.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 als CPMP-Guideline auch unter Internet: http://www.ema.europa.eu/pdfs/human/ich/273699en.pdf
Content:This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new active substances.
Document Type:ICH Guideline