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R106 - Keynote Presentation

‐ Jan 1, 2020 1:30pm

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.