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Archive for ‘September, 2008’

IPQ Special Report — September/October 2008

THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing. An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area. In the biotech context, the focus is shifting to the API and the challenges of defining critical quality attributes and design space for these complex molecules and processes.
September 24, 2008 | Posted in Issue Archive, Special Report | Read More »

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