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Yuqing Gong1, Francis-Xavier Barretto2, Yi Tsong3

  • 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, Maryland, 20993, USA.

The AAPS journal
|January 24, 2024
PubMed
概括

先进的定量方法为评估复杂的仿制药提供了新的途径,当传统的生物等价性测试不足时. 数据分析可以帮助为这些具有挑战性的产品开发合适的等价性评估方法.

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