Which phase of clinical trial conducted after a drug is marketed?
4 answers found
Phase I clinical trial is the first exposure of investigational medicinal product in humans and it sets the pillar for further clinical development.
However, the new guideline suggests an investigational new drug filing system, in which, the clinical trial may be initiated 60 working days after filing the application if no negative or questioned review opinions are received.
Clinical trials and drug approvals continue to accelerate in China.
01 Jul 2017•Lancet Oncology 11 citations