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ICH Q11 Development and Manufacture of Drug Substance slide image

ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance ICH Q11 Today's Agenda ■ Late breaking news ■ Background and Process for Q11 ■ Step 2 document - highlights & controversies ■■ Q11 Nomenclature Quiz * Design Space * QbD development versus QbD submission ✶ Platform Manufacturing * Control Strategy March 2012 ICI+ Slide 3
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