Abstract:
:Statistical assessment of bioavailability and bioequivalence of drug products is generally carried out with a univariate analysis by independently comparing each relevant parameter [such as, area under the drug concentration curve (AUC) and peak drug concentration (Cmax)] of the test and reference products. The assumption is made that AUC and Cmax are independent of each other. In reality, AUC, Cmax, and other pharmacokinetic parameters are dependent on each other. Therefore, a multivariate approach is theoretically superior. In this report, a novel multivariate approach to determine the bioavailability and bioequivalence of pharmaceutical products is described. The method determines the bivariate confidence ellipse (CE) between Cmax and AUC and the trivariate confidence ellipsoid (CED) among Cmax, AUC, and either Tmax or MRT for test and reference products. The similarity between the test and reference products can be assessed by the fraction of overlapping areas of CE and volumes of CED. The method and its comparison with conventional univariate analysis are demonstrated with data obtained from a bioequivalence study of ketoconazole tablets.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Hsu HC,Lu HL,Chan KKdoi
10.1002/jps.2600840620subject
Has Abstractpub_date
1995-06-01 00:00:00pages
768-72issue
6eissn
0022-3549issn
1520-6017pii
S0022-3549(15)49813-2journal_volume
84pub_type
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