|
|
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.
|
|
| Q3B(R2) Impurities in New Drug Products |
| Short Title: | Q3B(R2) |
| Internet: | http://www.ich.org/LOB/media/MEDIA421.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.emea.europa.eu/pdfs/human/ich/273899en.pdf |
| Content: | This ICH guideline (draft) provides recommendations for the limits and the qualification of impurities to be observed for the marketing authorization of medicinal products containing new active substances. After its resolution this revised guideline will in future replace the previous Q3B. |
| Document Type: | ICH Guideline |
|
|
|
|
|
