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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2005 FDA Advisory Committee <strong>for</strong>Pharmaceutical Science Meeting• FDA presented a proposal <strong>for</strong> delivered doseuni<strong>for</strong>mity testing– Goalposts are 80% to 120% of label claim– 87.5% coverage within the goalposts• IPAC-RS– Implementation of PTI test in this manner results in acoverage requirement that is greater than the designpoint (95.8% <strong>for</strong> “10/10/30/30 - 87.5%” test)– Even higher coverage is required when the mean isoff targethttp://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4187s1_Slide%20Index%20Day%201.htm22
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