Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
Pharmaceutical Development: ICH Q8/Q(8)R
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Product<br />
profile<br />
CQAs<br />
Risk<br />
assessment<br />
Design<br />
space<br />
Control<br />
strategy<br />
Continual<br />
Improvement<br />
Quality Target Product Profile<br />
“Begin with the end in mind”<br />
• Summary of the quality<br />
characteristics of a drug product<br />
to ensure safety and efficacy<br />
• Includes, but not limited to:<br />
• Dosage form<br />
• Route of administration<br />
• Pharmacokinetic characteristics<br />
• e.g., dissolution, aerodynamic performance<br />
• Quality characteristics for intended use<br />
• e.g., sterility, purity<br />
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