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Archive for ‘September, 2007’

IPQ Special Report — September/October 2007

APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small-molecule context. Establishing the linkage between quality attributes and clinical performance – a foundation block for the quality-by-design structure – is a particular challenge in the biotech arena, and pathways for tightening this linkage are being explored and discussed

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