Online Program Home
My Program

Abstract Details

Activity Number: 408 - SPAAC Poster Competition
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2018 : 2:00 PM to 3:50 PM
Sponsor: Scientific and Public Affairs Advisory Committee
Abstract #329757
Title: Agreement and Individual Bioequivalence: A New Look
Author(s): Tie-Hua Ng*
Companies: FDA/CBER
Keywords: Generics; Biosimilars; individual bioequivalence; interchangeability; concordance correlation coefficient; permutation test
Abstract:

Ng and Hshieh (2016) proposed graphical approaches using scatter plot, Bland-Altman plot and Q-Q plot to assess (i) individual bioequivalence of a generic drug and (ii) interchangeability of a proposed biosimilar product to a reference product. In this paper, concordance correlation coefficient (Lin, 1989) is used instead of the plots. Simulated and real data are used to illustrate the new method.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2018 program