Dear all,
even if in late, I've prepared a summary of the replies received for the
query submitted 20 days ago having as subject the Schuirmann test.
First of all many thanks to:
Adele Morganti, Paul Johnson, Jay Warner, David Scott, Tang Niansheng,
Roberto Ferrara, Melanie Wakelin and Mauro Gasparini for their precious
help.
The query was the following:
QUERY:
Dear Allstatters,
in bioequivalence studies there is a test which is often used to check for
the equivalence between two compounds/formulations in terms of PK/PD
parameters (AUC's, Cmax and so on). This test is the Schuirmann test
(known, also, as "Two one sided t-test").
How does it works ?
Can you, please, help me with some good reference ?
Thanks in advance.
Luigi
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The summary of the REPLIES :
Original abstract:
from Schuirmann with "interval hypotheses" formulation can be found in
Biometrics Vol. 37 p. 617 (1981).
Original paper :
Schuirmann, D.J. 1987. A comparison of the two one-sided tests procedure
and
the power approach for assessing the equivalence of average
bioavailability.
Journal of Pharmokinetics and Biopharmaceutics 15:657-680
Books, overview and related paper:
Overview : on bioequivalence testing by Westlake published on the Marcel
Dekker volume "Biopharmaceutical
Statistics for Drug Development" edited by Karl E. Peace.
Book : Design and analysis of bioavailability and bioequivalence studies /
Shein-Chung Chow, Jen-pei Liu. Published:
New York : M. Dekker, c1992.
Papers:
Nam, J. M. (1997). Establishing equivalence of two treatments and
sample size requirements in matched-pairs design. Biometrics 53, 1422-1430
Tango, T. (1998). Equivalence test and confidence interval for the
difference in proportions for the paired-sample design. Statist. in Med.
17,
891-908
Hsush, H. M. et al. (2001). Unconditional exact tests for
equivalence or noninferiority for paired binary endpoints. Biometrics 57,
273-278.
Liu and Weng: evaluation of parametric and nonparametric two one-sided
tests procedures for assessing bioequivalence of average bioavailability.
Journal of biopharmaceutical statistics 3:85-102, 1993
Anderson and Hauck: a new procedure for testing equivalence in comparative
bioavailability and other clinical trials. Commun. statist.- theor. meth
12:2663-2692, 1983
Westlake W J (1981) Bioequivalence testing - Biometrics 37, 589-594.
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Thanks again
Luigi
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