The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Andrea M. Pless
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Andrea M. Pless is an associate director at Teva
Articles by Andrea M. Pless
A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachPublished: October 2nd 2014 | Updated:
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