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Updated: Jun 13, 2025

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药物遗传学方法优化仿制药开发中的生物等价性研究

Jihyun Bae1, Jihong Shon1, Myong-Jin Kim1

  • 1Division of Therapeutic Performance II, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Journal of clinical pharmacology
|June 12, 2025
PubMed
概括

药物遗传学 (PGx) 考虑越来越多地用于仿制药开发,以提高安全性和效率. 对FDA指南的审查表明PGx信息有助于选择研究群体,改善药理动力学 (PK) 生物等价性 (BE) 研究.

关键词:
与药物动力学终点相关的生物等价性研究.开发仿制药的药物开发药物遗传学/药物基因组学产品特定的指南.监管/科学事务.

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