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Updated: May 8, 2025

Tactile Semiautomatic Passive-Finger Angle Stimulator TSPAS
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Tactile Semiautomatic Passive-Finger Angle Stimulator TSPAS

Published on: July 30, 2020

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对于使用公差区间来设定产品规范的统计考虑,对于正常分布的属性属性

Chang Chen1, Yi Tsong, Xutong Zhao

  • 1Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Evaluation.

Journal of biopharmaceutical statistics
|March 13, 2025
PubMed
概括

这项研究引入了一种精确的方法,用于使用耐受性间隔来确定药物产品质量规范. 它通过定义精度要求和确定适当的样本大小来确保准确的极限,防止过度规范.

关键词:
参数公差区间的公差区间品质标准 品质标准 品质标准产品质量规范 产品质量规范

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