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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Control Variability• There is uncharacterized variability in theexcipients and process– Level 1 handles variability <strong>by</strong> excessivelytesting– Level 2 handles variability <strong>by</strong> limited testingand establishing design space <strong>for</strong> criticalmaterial attributes and process parameters– Level 3 is a robust process that can ensurequality in the presence of uncharacterizedvariability29
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