ACCELERATED  APPROVAL׼
ADVERSE  EFFECT
ADVERSE  REACTIONӦ
AGENCYţָFDA
ANIMAL  TRIAL
ARCHIVAL  COPY浵ø
BENIFITS
CLINICAL  TRIALٴ
COS/CEP  ŷҩ֤
DRUG  PRODUCTҩƷ
DRUG  SUBSTANCEԭҩ
ESTABLISHED  NAMEȷ
GENERIC  NAMEר
ICHInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human  Use)ҩעἼҪЭ
ICHļΪȫԡЧԺۺѧ4ࡣ
IDENTITYα
INNINTERNATIONAL NONPROPRIETARY  NAMEʷר
INVESTIGATORоԱԱ
LABELED  AMOUNTʾ
NFNATIONAL  FORMULARYҴ
OFFICIAL COMPENDIUMҩ䣨ҪָUSP  NF
OFFICIALPHARMACOPEIAL=  COMPENDIALҩģģٷ
PREPARING AND  SUBMITTINGݺ걨
PROPRIETARY  NAMEרƣ
PROTOCOL
Q1:ҩƷȶ
Q2:ѧ
Q3:
Q4:ҩ
Q5:＼Ʒ
Q6:׼
Q7:GMP
Q7a:ԭҩ淶ָϣҩԳɷֵGMP.
REGULATORY  SPECIFICATION׼NDAṩ
REGULATORY  METHODOLOGY
REGULATORY METHODS  VALIDATION÷֤
REVIEW  COPYø
RISKSܺ
STANDARD  DRUG׼ҩ
STRENGTH񣻹ÿһλЧɷֵ
SUBMISSION걨ݽ
USPTHE UNITED STATES  PHARMACOPEIAҩ
ҪļQͷ,a,b,c,dС:
