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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 Biotechnological Products : Stability Testing of Biotechnological / Biological Products (CPMP/ICH/138/95) |
| Short Title: | Q5C |
| Internet: | http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002803.pdf |
| 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.ema.europa.eu/ |
| Content: | ICH guidelines for the quality of biotechnology products with respect to stability tests of biotechnology products. Binding for marketing authorization in USA, EU, Japan. |
| Document Type: | ICH Guidelines |
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