Design and statistical analysis of method transfer studies for biotechnology products

Shen Meiyu; Xu Lixin (Leo)

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Design and statistical analysis of method transfer studies for biotechnology products

机译：生物技术产品方法转移研究的设计与统计分析

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摘要

"We present our proposals for test materials and study designs of method transfer studies for biotechnology products, an equivalence test for comparing means obtained in two laboratories and a head-to-head approach for comparing precisions of the data obtained in two laboratories."

机译：“我们提出了用于生物技术产品的方法转移研究的测试材料和研究设计的建议，用于比较两个实验室中获得的手段的等效试验和用于比较两个实验室中获得的数据的精确方法的头脑前进方法。”

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来源
《Bioanalysis》 |2017年第8期|共6页
作者
Shen Meiyu; Xu Lixin (Leo);
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作者单位

US FDA Div Biometr 6 Off Biostat Off Translat Sci Ctr Drug Evaluat &

Res 10903 New Hampshire;

US FDA Div Drug Qual 1 Off Mfg Qual Off Compliance Ctr Drug Evaluat &

Res 10903 New Hampshire;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
analytical method; equivalence testing; method transfer; statistical analysis;

机译：分析方法;等价测试;方法转移;统计分析;

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Design and statistical analysis of method transfer studies for biotechnology products

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