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 1: Linking Material Attributes <strong>and</strong><br />
Process Parameters to Drug Substance CQA’s<br />
� Design space <strong>and</strong> manufacturing flexibility<br />
� Traditional <strong>and</strong> Enhanced Approach in determination<br />
<strong>of</strong> ranges <strong>for</strong> parameters<br />
� Development <strong>of</strong> a Design Space using prior<br />
knowledge <strong>and</strong> chemistry first principles. (not just<br />
DoE)<br />
� Using an enhanced approach to achieve<br />
manufacturing flexibility<br />
� Using set parameters in multivariate analysis
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