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Biotech QbD Encounters Uncertainties Over Definitions and Regulatory Relief

This article was originally published in The Gold Sheet

Executive Summary

As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.

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