Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Karen M. Alsante, Kim Huynh‐Ba, Steven W. Baertschi, Robert A. Reed, Margaret S. Landis, Scott Furness, Bernard A. Olsen, Mark D. Mowery, Karen Russo, Robert Iser,

AAPS PharmSciTech · 2013 · 43 citations · 33 references

Concepts

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