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 1 ControlAPI, fixed particle sizeMCC, grade specifiedCroscarmellose NaMg stearate<strong>Drug</strong>productTestAppearanceIdentityAssayUni<strong>for</strong>mityImpuritiesTablet weightHardnessFriabilityDissolutionFixed order of additionFixed load levelFixed # of revolutionsBlendUni<strong>for</strong>mityTestingFixed pre-compression <strong>for</strong>ceFixed compression <strong>for</strong>ceFixed press speedFixed feeder speed26