Journal of biopharmaceutical statistics
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The U. S. Pharmacopoeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. ⋯ This is especially true when the mean dissolution is close to the specification value. We proposed that the goal of the dissolution test sampling plan is to accept a lot at least 90% of the tablets dissolved more than a pre-specified amount Q at the specific time. The group sequential procedure derived accordingly is shown to outperform both USP and JP in controlling the type I error rate under normality assumption.