ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Special Thanks to John Donaubauer Abbott Vance Novack GSK Steve Mendivil Amgen Betsy Fritschel J&J Bryan Mobbs Astra Zeneca Wendy Mavroudakis J&J Rodney Parsons BMS Sally Anliker Lilly Jonathan Walker BMS Mark Butchko Lilly Andrew Gee Boehringer Ingleheim John Lepore Merck Linda Hendricks Centocor John Curran Merck Vincent Djuhadi Cephalon Tim Watson Pfizer Carly Evans Genzyme Zareen Ahmed Sanofi Clive Meerholz GSK March 2012 ICH Slide 38

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