This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
393
|
Type:
|
Topic Contributed
|
Date/Time:
|
Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #306340 |
Title:
|
Pharmacokinetics (PK) Comparability for Follow-On Biologics
|
Author(s):
|
Jason Liao*+
|
Companies:
|
Merck Research Laboratories
|
Address:
|
P.O.Box 4, WP37C-305, West Point, QC, 19486,
|
Keywords:
|
Biosimilarity ;
Follow-on biologics (FOB) ;
Comparability ;
Pharmacokinetics (PK) ;
Ratio of geometric mean (MGR) ;
Reference-scaled
|
Abstract:
|
With the rising spending and approaching patent expiration of biologics, biosimilar is a topic of much debate, not only among pharm and biotech companies, but also major regulatory bodies such as US FDA and the European Medicines Agency. The traditional classic chemical synthesized generic drug was introduced with only limited data needed for market approval, which, however, cannot be extrapolated to biologics. In the biologics scenarios, the comparability of efficacy and safety from the clinical trials, and the comparability of pharmacokinetics and pharmacodynamics parameters are the key for the success of follow-on biologics. In this talk, we focus on the comparability of pharmacokinetics. We propose a reference scaled method to demonstrate the comparability of pharmacokinetics parameters and a real data set is used to demonstrate the proposed approach.
|
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 2010 program
|
2010 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.