Statistical issues in bioequivalence [correction of bioequivalance].
There has been much work recently on individual bioequivalence and the topic has attracted considerable controversy. Some previous controversies regarding average bioequivalence are examined. It is argued that a contributory factor in these controversies may have been confusion over the purpose of bioequivalence trials. It is concluded that this purpose needs further clarification before guidelines for individual bioequivalence can be established and indeed that such guidelines may turn out to be unnecessary.
Senn
S
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Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London WC1E 6BT, U.K. stephens@public-health.ucl.ac.uk
D000927:Anticonvulsants / Q000493:pharmacokinetics; D019540:Area Under Curve; D001682:Biological Availability; D001993:Bronchodilator Agents / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000493:pharmacokinetics / Q000592:standards; D004983:Ethanolamines / Q000493:pharmacokinetics; D000068759:Formoterol Fumarate; D006801:Humans; D010672:Phenytoin / Q000493:pharmacokinetics; D013223:Statistics as Topic / Q000379:methods*; D013810:Therapeutic Equivalency
D000927:Anticonvulsants; D001993:Bronchodilator Agents; D016568:Drugs, Generic; D004983:Ethanolamines; D010672:Phenytoin; D000068759:Formoterol Fumarate