????????(Investigational New Drug Application, IND)????FDA???,????????????????????????????,????????:
-
??????:????????????????????????????????????????????????????????????????????????????
-
???????????:????????????????????????????????
-
????????????(Investigator)???:?????????????,??????????????????????????,?????????????????????????,????????????????????
????
-
?????Pre-IND??
-
?????????
-
?????
-
?????
-
?????????
-
????
-
??I???????
-
?????Pre-IND??????????
-
?????????(KOL)
-
?FDA?????Pre-IND??
-
??FDA?????????
-
?????IND????
-
?????IND??
-
?????????(PI)
-
????????
-
??IND?????
-
???????FDA??IND
? ?????“????”??,?????????