|
|
|
|
|
|
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.
|
|
| Q1C Stability Testing: Requirements for New Dosage Forms |
| Short Title: | Q1C |
| Internet: | http://private.ich.org/LOB/media/MEDIA413.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/028095en.pdf |
| Content: | This guideline defines the circumstances under which reduced stability data can be accepted, at the time of filing an application, in the case of new formulations of already approved medicines |
| Document Type: | ICH Guideline |
|
|
|
|
|
|
