RT Book, Section
A1 Hafley, Gail E.
A1 Leonardi, Sergio
A1 Pieper, Karen S.
A2 Lopes, Renato D.
A2 Harrington, Robert A.
SR Print(0)
ID 57836005
T1 Chapter 8. Phase III and IV Clinical Trials
T2 Understanding Clinical Research
YR 2013
FD 2013
PB The McGraw-Hill Companies
PP New York, NY
SN 978-0-07-174678-6
LK accessbiomedicalscience.mhmedical.com/content.aspx?aid=57836005
RD 2024/04/20
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.