TY  - CHAP
M1  - Book, Section
TI  - The Road to Drug Approval
A1  - Graham, Thomas J.
Y1  - 2018
N1  - 
T2  - Innovation the Cleveland Clinic Way: Powering Transformation by Putting Ideas to Work
AB  - The  U.S.  Food  and  Drug  Administration  (FDA)  drug  approval  process  has  nine  stages  (fda.gov).  They  are  organic  research;  target  identification  and  validation;  determination  of  a  lead  compound;  ADME/tox  testing;  compound  optimization;  preclinical  testing;  investigational  new  drug  (IND)  application;  clinical  trials  (Phases  1,  2,  and  3);  new  drug  application  (NDA);  manufacture  and  scaling;  and  Phase  4  testing.  Each  step  is  described  in  detail  in  this  appendix,  with  an  eye  to  how  it  contributes  to  the  ultimate  expense  of  drug  development  (see  fda.gov).  
SN  - 
PB  - McGraw-Hill Education
CY  - New York, NY
Y2  - 2024/04/17
UR  - accessmedicine.mhmedical.com/content.aspx?aid=1150321276
ER  -