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Woodcock J, case evaluation concept of pharmaceutical high quality. American Pharmaceutical Review, 76, 2004, p. 10–15. 2. Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006. 3. Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2007. 4. Lionberger RA, Lee LS, Lee L, Raw case solution ,Yu LX, Quality by layout: Concepts for ANDAs, case analysis AAPS Journal, 10, 2008, p.
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