Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
Q11 Development of APIs Training Introduction - TRIPHASE Pharma ...
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ICH <strong>Q11</strong> – <strong>Development</strong> & Manufacture <strong>of</strong>Drug SubstancesOutline• Background to ICH <strong>Q11</strong>• Overview <strong>of</strong> <strong>Q11</strong> at Step 3• Next steps <strong>of</strong> ICH process© 2011 ICH 3
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