Bayesian approach to bioequivalence assessment: an example.

The statistical methods required for a Bayesian analysis of bioequivalence are outlined and numerically illustrated. The analysis consists of the calculation of the posterior probability, given the experimental results, that the ratio of true means of a new and a standard formulation of a drug with respect to some biological response lies in a given interval. Nomograms helpful for the calculation of these probabilities are provided.

The renal elimination of rifampicin as a function of the oral dose. A convenient way to assess relative bioavailability.

A spectrophotometric method for the quantitative determination of rifampicin in urine is described and its specificity and precision are discussed. It is shown that the mean cumulative urinary elimination of rifampicin is reproducible when the same dose is administered twice in two different experiments to the same group of volunteers. The percentage of the amount eliminated increases with increasing dose.