TY  - CHAP
M1  - Book, Section
TI  - Chapter 16. Impact of Drug Product Quality and Biopharmaceutics on Clinical Efficacy
A1  - Shargel, Leon
A1  - Wu-Pong, Susanna
A1  - Yu, Andrew B.C.
PY  - 2012
T2  - Applied Biopharmaceutics & Pharmacokinetics, 6e
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.  
SN  - 
PB  - The McGraw-Hill Companies
CY  - New York, NY
Y2  - 2024/04/19
UR  - accesspharmacy.mhmedical.com/content.aspx?aid=56605785
ER  -