Clinical cross-over trials in phase I.
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.
Senn
S
S
Department of Statistical Science, University College London, UK. stephens@public-health.ucl.ac.uk
Ezzet
F
F
D001682:Biological Availability; D001699:Biometry; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D006801:Humans; D016014:Linear Models; D008954:Models, Biological; D015233:Models, Statistical; D017711:Nonlinear Dynamics; D010599:Pharmacokinetics; D010600:Pharmacology; D012449:Safety; D013810:Therapeutic Equivalency