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Implementation of Quality-by-Design (QbD) Principles in CMC Review of Generic Drugs

Implementation of Quality-by-Design (QbD) Principles in CMC Review of Generic Drugs. Lawrence X. Yu, Ph. D. Director for Science Office of Generic Drugs Food and Drug Administration. Advisory Committee for Pharmaceutical Science October 26, 2005. OGD Question-based Review System. Why?

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Implementation of Quality-by-Design (QbD) Principles in CMC Review of Generic Drugs