Bioavailability -- A Problem in Equivalence

SUMMARY Bioavailability is an important area of pharmaceutical research containing many questions which are not yet resolved. This paper specifies some of the medical and pharmacological questions which need to be clarified before a statistician can make his contribution to a bioavailability study. The statistical considerations for designing and analyzing bioavailability studies are stated and various statistical approaches are listed. Suggestions are given for research in statistical methodology as applied to bioavailability studies. References to the literature of bioavailability experiments are provided. A number of issues have converged in recent years to focus increasing attention on an area of medical therapeutics which has come to be known as Some of these issues are: the rising cost of medical care; the increasing involvement of Federal, state, and local governments in the financing and therefore the control of medical treatment; the consumerism movement and its scrutiny of the profits of the drug industry as they relate to the cost of medications; the cost factors associated with the researching of new drugs; the increasing regulatory activities of government; and the role of the pharmacist in the delivery of medicine to the patient. Assessment of bioavailability itself is a scientific problem, and statistics can make a significant contribution to its resolution. This paper presents some statistical aspects of bioavailability.