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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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| Quality of Biotechnology Products : Analysis of the Expression Construct in Cells Used for Productions of r - DNA - Derived Protein Products (CPMP/ICH/139/95) |
| Short Title: | Q5B |
| Internet: | http://www.emea.europa.eu/index/indexh1.htm |
| Origin/Publisher: | Sector for Document Management and Publishing, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK, http://www.emea.europa.eu/ |
| Content: | ICH guidelines for the quality of biotechnology products with respect to the analysis of expression vectors in cells used for the production of proteins originating from DNA. Binding for marketing authorization in USA, EU, Japan. |
| Document Type: | ICH Guidelines |
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