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Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD

  Рет қаралды 9,694

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

FDA discusses case studies on how to establish clinically relevant impurities specifications.
Presenter:
Hongbiao Liao, Division of Lifecycle API
Learn more at: www.fda.gov/dr...
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