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R106
Keynote Presentation
Date
January 1, 2020
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Analytics play a critical role in assuring product quality through release testing, process control, deep characterization, defining critical quality attributes, comparability and analytical similarity. A framework that would facilitate the use of this information and allow for effective knowledge management will enhance quality control strategies and drug development. This concept is explored. Bioassays are a key part of analytics for quality; Such assays and biological models in general can also facilitate effective clinical development of drugs. Communication and structures that leverage biology across disciplines may enhance drug development.
Speaker
Steven Kozlowski, M.D.
CDER, FDA
Tracks
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