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Quality by Design: Next Steps to Realize Opportunities? - page 33 / 37

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What steps (is) should FDA (taking) take to realize the benefits of QbD?

While the ICH process on Pharmaceutical Development is ongoing

Focus on SUPAC-C concept

Work with/within the draft Comparability Protocol Guidance

Is this format too restrictive?

In addition to Comparability Protocol concept develop additional guidance on SUPAC-C

Appendix to Comparability Protocol?

Planned revisions of current SUPAC guidance?

Independent SUPAC-C guidance?

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