Reisensburg 1997: Abstract Hauschke
Statistical Computing '97 - Schloß Reisensburg
Sample Size Determination for the Cross-over Design
Dieter Hauschke, Martin Burke, Edgar Diletti
Department of Biometry
Byk Gulden Pharmaceuticals
The recent note for guidance "Biostatistical methodology in clinical trials
in applications for marketing authorizations for medical products" ,
published in 1994 by the European
Committee for Proprietary Medicinal Products (CPMP),
requires that for the primary efficacy
characteristic the sample size determination has to be stipulated in the
study protocol prior to
starting the clinical trial.
A commonly used experimental setting in clinical trials is the
two-period, two-sequence cross-over design.
However, only a limited number of publications
address to the corresponding sample size calculation.
Therefore, consideration of this topic is
given in this presentation for equivalence and difference testing between
Diletti, E., Hauschke, D. and Steinijans, V.W. (1991):
Sample size determination for bioequivalence assessment by means of
confidence intervals. International
Journal of Clinical Pharmacology and Toxicology 29, 1-8.
Hauschke, D., Steinijans, V.W., Diletti, E. and Burke, M. (1992):
Sample size determination for bioequivalence assessment using a
multiplicative model. Journal of
Pharmacokinetics and Biopharmaceutics 20, 557-561.
Hauschke, D. Burke, M. and Diletti, E. (1997):
Sample size determination for the cross-over design. In: Vollmar, J. and
Hothorn, L.A. (eds) Biometrie in
der chemisch-pharmazeutischen Industrie, Vol. 8: Cross-over clinical trials
Owen, D.B. (1965):
A special case of a bivariate non-central t-distribution. Biometrika 52,
Phillips, K.F. (1990):
Power of the two one-sided tests procedure in bioequivalence. Journal of
Biopharmaceutics 18, 137-144.
29. Statistical Computing '97 ---