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Statistical Methods in Medical Research
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What's this?

Clinical cross-over trials in phase I

Stephen Senn

University College London, London, UK, stephens{at}public-health.ucl.ac.uk

Farkad Ezzet

Novartis Pharma, Basle, Switzerland

We review the role of cross-over trials in pharmacokinetic and pharmacodynamic studies, in particular as applied in phase I. Design and analysis considerations are covered. We also consider the use of pharmacokinetic and pharmacodynamic theories in planning cross-over trials. Finally some practical considerations are covered.

Statistical Methods in Medical Research, Vol. 8, No. 3, 263-278 (1999)
DOI: 10.1177/096228029900800306
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