Articles by Helen N. Winkle - Pharmaceutical Technology

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Articles by Helen N. Winkle

Helen N. Winkle
FDA Perspectives: Understanding Challenges to Quality by Design
September 2, 2011
By: Helen N. Winkle , Moheb M. Nasr

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

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