Quality by Design for Orally Inhaled Drug Products - PQRI
Quality by Design for Orally Inhaled Drug Products - PQRI
Quality by Design for Orally Inhaled Drug Products - PQRI
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Level 2 ControlWDS = Within <strong>Design</strong> SpaceAPI, particle size WDSMCC, particle size WDSCroscarmellose NaMg stearate<strong>Drug</strong>productTestAppearanceIdentityAssayUni<strong>for</strong>mityImpuritiesTablet weightHardnessFriabilityDissolutionFixed order of additionWDS load levelWDS # of revolutionsBlendUni<strong>for</strong>mityTestingWDS pre-compression <strong>for</strong>ceWDS compression <strong>for</strong>ceWDS press speedWDS feeder speedTesting may bereduced if predictedfrom input and processparameters27
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