A spreadsheet program for simulation of bioequivalence and bioavailability studies.
This paper presents a spreadsheet for Excel for Windows, which simulates bioequivalence (BE) trials. The program incorporates intersubject and intrasubject variability in drug absorption and disposition as well as assay precision and the uniformity of the administered dose. The output provides confidence intervals and a pass/fail code for each study. This program is useful for simulating BE trials using widely available and simple-to-use spreadsheet programs. An example of the application of the program in assessing the influence of intrasubject variability on the outcome of BE testing of two identical formulations is also presented.
Abdallah
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Division of Biopharmaceutics, the Food and Drug Administration, Rockville, Maryland, USA.
Ludden
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TM
D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D016001:Confidence Intervals; D018592:Cross-Over Studies; D006801:Humans; D007408:Intestinal Absorption; D008657:Metabolic Clearance Rate; D015588:Observer Variation; D012680:Sensitivity and Specificity; D012984:Software; D013810:Therapeutic Equivalency