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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<strong>Design</strong> Space• <strong>Design</strong> Space– The multidimensional combination and interaction ofinput variables (eg. material attributes) and processparameters that have been demonstrated to provideassurance of quality• Regulatory Implication– Movement out of the design space is considered tobe a change and would normally initiate aregulatory post-approval change process. <strong>Design</strong>space is proposed <strong>by</strong> the applicant and is subject toregulatory assessment and approval19
Change language