RT Book, Section
A1 Watt, Kevin M.
A1 Chiswell, Karen
A1 Cohen-Wolkowiez, Michael
A2 Lopes, Renato D.
A2 Harrington, Robert A.
SR Print(0)
ID 57835652
T1 Chapter 6. Phase I Trials: First in Human
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=57835652
RD 2024/04/24
AB The  development  process  for  a  new  molecular  entity  (NME)  in  humans  proceeds  over  several  phases  of  clinical  trials  (I  through  III)  before  it  can  be  approved  for  marketing  by  national  regulatory  authorities  (Figure  6–1).  Once  regulatory  approval  has  been  obtained,  after  undergoing  all  required  trials  over  many  years,  NMEs  translate  into  drugs  that  are  used  to  treat  specific  conditions.