Helen Winkle

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Helen Winkle is director of the Office of Pharmaceutical Science.

Articles

Quality by Design for Generic Drugs

Quality by Design for Generic Drugs

Robert Lionberger;Gordon Johnston;Lawrence X. Yu;Gary Buehler;Michael C. Olson;Helen Winkle

October 2nd 2009

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

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