Topic 1. Challenges and Considerations for Implementation of ICH ...
Topic 1. Challenges and Considerations for Implementation of ICH ...
Topic 1. Challenges and Considerations for Implementation of ICH ...
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Breakout Session Overview<br />
Example 3: Presentation <strong>of</strong> A Design Space <strong>for</strong><br />
A Biotechnological Product Unit Operation<br />
� Analogous to <strong>ICH</strong> Q8R2, example 2 where a two<br />
parameter design space consists <strong>of</strong> the overlap<br />
region <strong>for</strong> two CQAs<br />
� Q11 example 3 shows the common region <strong>of</strong><br />
successful operating ranges <strong>for</strong> three CQAs<br />
� In addition, the successful operating range <strong>for</strong> one<br />
CQA (residual DNA) was derived from prior<br />
knowledge (plat<strong>for</strong>m manufacturing)
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