RT Book, Section
A1 Shargel, Leon
A1 Wu-Pong, Susanna
A1 Yu, Andrew B.C.
SR Print(0)
ID 56605785
T1 Chapter 16. Impact of Drug Product Quality and Biopharmaceutics on Clinical Efficacy
T2 Applied Biopharmaceutics & Pharmacokinetics, 6e
YR 2012
FD 2012
PB The McGraw-Hill Companies
PP New York, NY
SN 978-0-07-160393-5
LK accesspharmacy.mhmedical.com/content.aspx?aid=56605785
RD 2024/04/23
AB Side  effects  from  the  use  of  drugs  are  the  major  cause  of  drug-related  injuries,  adverse  events,  and  deaths.  The  FDA  (FDA,  CDER,  2005,  2007)  has  summarized  various  types  of  safety  and  efficacy  risks  from  medicines  (Fig.  16-1).  Side  effects  are  observed  in  clinical  trials  or  postmarketing  surveillance  and  result  in  listing  of  adverse  events  in  the  drug's  labeling.