ICH Demystifies Q11 Guide on Selection of Starting Materials

Executive Summary A new Q&A document finalized by the International Council for Harmonisation aims to clarify and harmonize the information that companies should include in their marketing applications on the selection of starting materials for manufacturing drug substances.

Executive Summary

A new Q&A document finalized by the International Council for Harmonisation aims to clarify and harmonize the information that companies should include in their marketing applications on the selection of starting materials for manufacturing drug substances.

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Source: pink.pharmamedtechbi.com