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Tie Hua Ng, Ph. D.

FDA/CBER, Silver Spring, Maryland



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408 – SPAAC Poster Competition

Agreement and Individual Bioequivalence: A New Look

Sponsor: Scientific and Public Affairs Advisory Committee
Keywords: Generics, Biosimilars, individual bioequivalence, interchangeability, concordance correlation coefficient, permutation test

Tie Hua Ng, Ph. D.

FDA/CBER, Silver Spring, Maryland

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.

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