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Theoretical Purge Argumentation for Genotoxic Impurities

pdf fileSchulte Oestrich R; Baumann J-C;

Presented by Jens-Christoph Baumann and Rolf Schulte Oestrich, from Roche, at the Lhasa Limited 44th ICGM in Basel, 2016.

This presentation discusses ICH M7, and the control of process-related impurities. 



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