QbD, control strategy and the regulatory experience
GERALD C. DIDONATO*, STEPHEN M. LIEBOWITZ
*Corresponding authorBristol-Myers Squibb Company P.O. Box 5400 Princeton, NJ 08534, USA
Abstract
Quality by Design (QbD) is a science and risk-based approach topharmaceutical development. Products developed under a QbDparadigm create a knowledge base to formulate a holistic controlstrategy that assures conformance of a drug product to its intendedperformance profile. Saxagliptin, a new drug for the treatment ofType II diabetes, was developed under QbD principles and submittedfor regulatory approval in the US, EU and several other countries.Development experimentation to support the control strategy and itspresentation in the applications are discussed.
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