Regarding an acceptance criterion of "water content" specified for drug product, could it be established by the upper one-sided and lower one-sided 95% confidence limit at the end of shelf life with 6-month data of "water content" in long-term and accelerated stability?

刊登日期:2019-11-22  |  點閱次數 : 1480 次 

No, the data is insufficient. The impact on the product quality attributes affected by water content, such as "related substances", "assay", "microbiological limit test", etc., should be evaluated to predict the outcome at the end of shelf-life. In addition, regression analysis and calculation data should be provided (if appropriate).



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