TY  - CHAP
M1  - Book, Section
TI  - Investigational Drugs
A1  - J. Grilley, Bambi
A2  - Malone, Patrick M.
A2  - Witt, Benjamin A.
A2  - Malone, Meghan J.
A2  - Peterson, David M.
PY  - 2022
T2  - Drug Information: A Guide for Pharmacists, 7e
AB  - Learning  ObjectivesAfter  completing  this  chapter,  the  reader  will  be  able  to:List  the  major  legislative  acts  that  led  to  the  current  system  of  drug  evaluation,  approval,  and  regulation  used  in  the  United  States.List  the  steps  in  the  drug  approval  process.List  the  components  of  an  Investigational  New  Drug  Application  (IND).Describe  the  difference  between  commercial,  treatment,  emergency  use,  and  individual  investigator  INDs.Define  orphan  drug  status  and  list  the  advantages  of  classifying  a  drug  as  an  orphan  drug.List  all  of  the  requirements  (as  specified  by  the  Office  of  Human  Research  Protections  [OHRP])  for  an  institutional  review  board  (IRB).Prepare  appropriate  protocol  assessments  for  use  by  the  IRB  or  other  review  committees  when  they  evaluate  new  human  subject  protocols.Describe  the  type  of  support  that  is  necessary  for  clinical  research,  including  (but  not  limited  to)  the  following:Ordering  drug  supplies  for  ongoing  clinical  trialsMaintaining  drug  accountability  records  as  required  by  the  Food  and  Drug  Administration  (FDA)Preparing  drug  and  protocol  data  sheets  for  use  by  health  care  personnel  in  the  hospitalPreparing  pharmacy  budgets  for  sponsored  clinical  researchAiding  investigators  in  designing  and  conducting  clinical  trials  in  their  institutionAssisting  investigators  in  initiating  and  conducting  clinical  trials  (including  emergency  use  INDs)  
SN  - 
PB  - McGraw Hill
CY  - New York, NY
Y2  - 2024/04/25
UR  - accesspharmacy.mhmedical.com/content.aspx?aid=1190461983
ER  -