ICH Q11 Development and Manufacture of Drug Substance slide image

ICH Q11 Development and Manufacture of Drug Substance

ICH Quality Guideline Q11 Development and Manufacture of APIs (An Update from the Trenches) Steven Mendivil (Amgen) Special thanks to Betsy Fritschel & Tim Watson March 2012 International Conference on Harmonisation of Technical TUTH Requirements for Registration of Pharmaceuticals for Human Use ICI+
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