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Home » ICH GUIDANCE SUGGESTS PARAMETERS FOR COMPARABILITY STUDIES
ICH GUIDANCE SUGGESTS PARAMETERS FOR COMPARABILITY STUDIES
March 29, 2004
The FDA has released an international draft guidance to help makers of biological and biotechnological drugs design studies to assess the comparability of products before and after changes are made to the manufacturing process. Such studies determine whether a manufacturing change adversely affects the quality, safety and efficacy of the product.