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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Design Space (<strong>ICH</strong> <strong>Q8</strong>)<br />
Product<br />
profile<br />
CQAs<br />
Risk<br />
assessment<br />
Design<br />
space<br />
Control<br />
strategy<br />
Continual<br />
Improvement<br />
• Definition<br />
• The multidimensional combination and<br />
interaction off input variables (e.g., material<br />
attributes) and process parameters that have<br />
been demonstrated to provide assurance of<br />
quality<br />
• Regulatory flexibility<br />
• Working within the design space is not<br />
considered a change<br />
• Important to note<br />
• Design space is proposed by the applicant and<br />
is subject to regulatory assessment and<br />
approval<br />
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