FAQ
Drugs

Is there a basis to set the acceptance criteria of the organic impurities in the specifications of drug substance and drug product for investigational new drug (IND) applications?

刊登日期:2019-11-11  |  點閱次數 : 555 次 

Yes. At the clinical trial stage, the acceptance criteria of the organic impurities should be supported by the results of related toxicology studies.

 

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