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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published August 2009. link] Figure 2: Development process flow diagram. The results of the risk assessment are used to define experiments. 12 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q8 (R2): Pharmaceutical Development.”

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published August 2009. link] Figure 2: Development process flow diagram. The results of the risk assessment are used to define experiments. 12 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q8 (R2): Pharmaceutical Development.”