FAQ
Drugs

Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?

刊登日期:2020-07-22  |  點閱次數 : 755 次 

In principle, it is not required to submit separate DMFs for the same drug substance with different particle size distributions, particle size distributions may be listed in the drug substance specification. 

 

(中文版)


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