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The Quantification of Injectability by Mechanical Testing
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Leveraging Model Master Files for Long-Acting Injectables

Yuqing Gong1, Robert Hopefl1, Tonglei Li2

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.

Pharmaceutical Research
|January 28, 2025
PubMed
Abstract

Keywords:
long acting injectablesmodel integrated evidencemodel master file

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