FAQ
Drugs

【Pharm/Tox】The sponsors need to provide nonclinical pharmacology/toxicology data and nonclinical pharmacokinetic data when applying the first-in-human clinical study. Does the full report of each nonclinical study need to be submitted besides the investigator’s brochure?

刊登日期:2019-11-11  |  點閱次數 : 540 次 

Yes. The sponsors need to provide not only investigator’s brochure but also the full report of each nonclinical PK studies and pivotal nonclinical safety studies when applying the first-in-human clinical study.
 

(中文版)


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