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 SubstancesGlossary• Platform Manufacturingo The approach <strong>of</strong> developing a production strategy for anew drug starting from manufacturing processes similar tothose used by the same applicant to manufacture otherdrugs <strong>of</strong> the same type (e.g as in production <strong>of</strong>monoclonal antibodies using predefined host cell, cellculture and purification process, for which there existsconsiderable experience)© 2011 ICH 22
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