TY  - CHAP
M1  - Book, Section
TI  - Chapter 8. Phase III and IV Clinical Trials
A1  - Hafley, Gail E.
A1  - Leonardi, Sergio
A1  - Pieper, Karen S.
A2  - Lopes, Renato D.
A2  - Harrington, Robert A.
Y1  - 2013
N1  - 
T2  - Understanding Clinical Research
AB  - Phase  III  trials  are  typically  undertaken  after  Phase  II  studies  have  identified  a  potentially  safe  and  effective  dose  that  is  considered  likely  to  show  an  effect  on  a  relevant  clinical  end  point.  Typically,  regulatory  approval  in  the  United  States  requires  two  statistically  significant,  well-controlled  clinical  trials  for  the  same  indication.  
SN  - 
PB  - The McGraw-Hill Companies
CY  - New York, NY
Y2  - 2024/04/16
UR  - accessmedicine.mhmedical.com/content.aspx?aid=57836005
ER  -