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.

	Are stability data required for the submission of an investigational new drug (IN
	What CMC data of active controls or concomitant drugs should be submitted for inv

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