2005 · 16 citations · 6 references
PharmacyPharmaceuticsPharmacologyDissolution TestingOral Drug DeliveryPharmaceutical FormulationComparative Dissolution TestingDissolution Profile ComparisonDrug DissolutionDrug SolubilityIn Vitro Dissolution TestingTablet FormulationComparison Method ValidationDissolution SpecificationsDissolution Test Method ValidationDrug Product ComparabilityImmediate Release Dissolution TestingImmediate-release Profile ComparisonPost-approval ChangesProduct Quality Improvement
Three categories of dissolution test specifications for immediate re-lease drug products are described in the guidance. Single point speci-fications are recommended as a routine quality control test for highly soluble and rapidly dissolving drug products. This comparison method
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Mathematical comparison of dissolution profiles
J. W. Moore, Henry H. Flanner · Pharmaceutical technology · 1996 · 1.1K citations