UCI Statistics Seminar

Thursday, April 18, 2002
1:50-2:15: Reception (coffee & cookies)
2:15-3:15: Seminar
3:15-3:50: Informal discussion with the speaker
Room 107, Administration Building

Naitee Ting, PhD

Associate Director II, Biostatistics
Pfizer Global Research & Development, Groton, CT

Title
ALTERNATIVE CONFIDENCE INTERVALS
for the Assessment of Bioequivalence in Four-Period Crossover Designs

Abstract:

Bioequivalence studies are conducted to demonstrate equivalence in the bioavailability of the active ingredient in different formulations. The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies to show bioequivalence between generic drugs and brand drugs before approval. A recent FDA guidance on bioequivalence proposes criteria for assessment of population bioequivalence (PBE) and individual bioequivalcence (IBE) in a four-period crossover design. In this presentation, computer simulation is used to compare modified large sample (MLS) upper bounds with those proposed by the FDA to test for both PBE and IBE. The comparison criteria are the ability to maintain the stated confidence level and the simulated power of tests based on these bounds.

Directions
Directions to the UCI campus can be obtained from the UCI WEB site at
http://www.uci.edu/campusmap/freeway.html

Once on campus, parking information can be obtained at the kiosk for Parking Structure #4 (PS4) located on the corner of West Peltason Drive and Campus Drive, directly across from the Student Center (113). These buildings can be found in the blue area of the campus map
(if you enlarge it sufficiently (eg. 300%))
http://www.uci.edu/campusmap/UCI.pdf

The seminar will be held in Room 107 of the Administration Building (111),
and the Administration Building can be found in the blue area of the campus map, when enlarged.

For further information
contact the UCI Center for Statistical Consulting
[949] 824-1680 or stats@uci.edu