ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Example 1 ◉ This example illustrates development of a design space using prior knowledge and chemistry first principles. It depicts both a traditional and enhanced approach to determination of the ranges for parameters controlling the formation of a hydrolysis impurity Value: high priority for PhRMA LDKIT Multivariate design is NOT DoE, Drug substance has many tools to develop and design space. * Demonstrate "fixed parameters" in MVD (eg. reflux temperature) Example proposed, developed, and supported by both regulators and industry ■ Not a complex example, and very "basic"; BUT the intent is very valuable to the disciple of drug substance. March 2012 ICH 2222 Slide 22

View entire presentation