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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What is Pharmaceutical <strong>Quality</strong>?• Janet Woodcock– Free of contamination and reproducibly delivering thetherapeutic benefit promised in the label to theconsumerPharmaceutical <strong>Quality</strong>= (<strong>Drug</strong> substance, excipients,manufacturing, and packaging)• <strong>Quality</strong> cannot be tested into products; quality canonly be built into products3