|
Activity Number:
|
93
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, July 30, 2007 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #309390 |
|
Title:
|
Design and Analysis of Method Transfer Studies in Nonclinical Pharmaceutical Development
|
|
Author(s):
|
Jinglin Zhong*+ and Yi Tsong
|
|
Companies:
|
Food and Drug Administration and Food and Drug Administration
|
|
Address:
|
CDER, 9758 pleasant gate lane, Potomac, MD, 20854,
|
|
Keywords:
|
concordance correlation ; tolerance interval ; individual equivalence
|
|
Abstract:
|
Analytical method transfer is an important part of analytical method development and maintenance. The current common practice of analytical method transfer is based on the equivalence of the means between the development laboratory and the production laboratory. However the most scientific sound approach would show the equivalency of individual sample readings between the two laboratories. In this talk, statistical approaches such as concordance correlation and tolerance interval approach to address individual equivalence between laboratories will be discussed. These approaches will be compared with each other and also with the mean equivalence approach on their statistical properties. Examples and simulation results will be presented to illustrate each analysis approach and the comparisons.
|
