IN-VIVO DISSOLUTION RATES - AN ERROR ANALYSIS

The uncertainty associated with the determination of in vivo dissoluti on rates was determined by Monte Carlo simulation. Error was imposed u pon sets of artificially generated data that simulated plasma drug lev els after tablet and solution dosage from ingestion. Deconvolutions we re performed on the data sets to determine how error in the plasma lev els propagated into the in vivo dissolution determinations. Two approa ches were taken in the performance of the deconvolution step of the si mulation. In the first, a model was explicitly assumed for dissolution . In the second, deconvolution was accomplished by a mass balance appr oach in which no explicit model for dissolution was assumed.