The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
|
Activity Number:
|
306
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Tuesday, August 2, 2011 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #302374 |
|
Title:
|
Graphical Analysis of Safety Data in NDA Submissions
|
|
Author(s):
|
Linyun Zhou*+
|
|
Companies:
|
Takeda Global R&D
|
|
Address:
|
One Takeda Parkway, Deerfield, IL, 60015,
|
|
Keywords:
|
graphical analysis ;
relative risk ;
patient narrative ;
DILI plots
|
|
Abstract:
|
Patient safety has always been a primary focus in the development of new pharmaceutical products. The predominant method for statistical evaluation and interpretation of safety data collected in a clinical trial is the tabular display of descriptive statistics. There is a great opportunity to enhance evaluation of drug safety through the use of graphical displays, which can convey multiple pieces of information concisely and more effectively than can tables. From some approved NDA submission, this paper provides graphical analysis in some key safety data. The graphical displaying safety data in this paper primarily focus on patient narratives, relative risk and adverse event, DILI plots for liver function, and line plots for multiple laboratory safety parameters and/or vital signs.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.