Considerable cost savings through the analysis of pooled plasma samples in bioequivalence studies that fail to show bioequivalence.

Abstract

A major part of the cost of bioequivalence studies is due to the drug assays of the individual plasma samples collected from each volunteer. Considerable savings in manpower, time, and especially costs could be achieved if it could be determined before the individual plasma samples are assayed that bioequivalence can not be shown. Such information can in fact be obtained through the analysis of pooled plasma samples. We propose an approach where pooled plasma samples are assayed and the resulting pooled drug concentration profiles for the test and reference product are compared. If this comparison indicates that one will not be able to show bioequivalence in the statistical analysis of the individual data, the individual plasma samples are not assayed. Thus more than 40% of the cost of a bioequivalence study that fails to show bioequivalence can be saved.