Where should data of constitution or dilution studies performed as part of the formal stability studies to confirm product quality through shelf-life be provided?

刊登日期:2019-11-13  |  點閱次數 : 1343 次 

In order to understand the compatibility of the drug product with the reconstitution diluents, relevant studies must be conducted to support the claims on the label. The data of the studies should be included in 3.2.P.2.6. If the study data is performed as part of the formal stability studies, the relevant results should be presented in 3.2.P.8.3.



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