A novel bending point criterion for dissolution profile interpretation.

A novel bending point criterion was developed and compared with a number of existing criteria for the interpretation of certain dissolution profiles; these comparison criteria were the percentage dissolved at a fixed time point, the fitted Weibull parameters, and the area under the dissolution curve (AUC). The statistical bending point model was applied to dissolution curves that showed linear dissolution. The bending point model is based on a general linear model, and its confidence information is obtained using the variance-covariance matrix of the parameter estimates.