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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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| Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process |
| Short Title: | Q5E |
| Internet: | http://www.ich.org/LOB/media/MEDIA1196.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/572103en.pdf |
| Content: | The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. |
| Document Type: | ICH Guideline |
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