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Abstract

A method and apparatus for optimally performing dissolution testing of pharmaceutical dosage forms, agricultural products, and components of industrial products wherein the method uses dissolution profiles from a known drug dosage form, or product, as reference data for a predictive process; and the apparatus is organized to carry out the method via both closed loop and open loop operating modes under the control of a central processor. An illustrative embodiment teaches the serial usage of the two operating modes in a single flow-through dissolution cell configuration to optimally predict the time course of in vivo bioavailability from in vitro dissolution measurements, while an alternate embodiment teaches the use of a plurality of dissolution cells and the simultaneous use of the closed and open loop operating modes to implement an Internal Standard capability. Additionally, an optimally adaptive capability is provided in the dissolution testing process via a random input modeling mode of operation.

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First Claim