Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

Izydor Apostol; Drew Kelner; Xinzhao Grace Jiang; Gang Huang; Jette Wypych; Xin Zhang; Jessica Gastwirt; Kenneth Chen; Szilan Fodor; Suminda Hapuarachchi; Dave Meriage; Frank Ye; Leszek Poppe; Wojciech Szpankowski

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Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

机译：基于当前信息的纯度测量的不确定度估计：走向纯度方法的“实时验证”

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摘要

To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry.

机译：预测色谱纯度方法的精度和其他性能特征，这些方法代表了生物制药行业中最广泛使用的分析形式。

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来源
《Pharmaceutical Research》 |2012年第12期|p.3404-3419|共16页
作者
Izydor Apostol; Drew Kelner; Xinzhao Grace Jiang; Gang Huang; Jette Wypych; Xin Zhang; Jessica Gastwirt; Kenneth Chen; Szilan Fodor; Suminda Hapuarachchi; Dave Meriage; Frank Ye; Leszek Poppe; Wojciech Szpankowski;
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作者单位

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Global Analytical Sciences, Longmont, Colorado, 80503, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Clinical Quality, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Analytical Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Product Attribute Sciences, Thousand Oaks, California, 91320, USA;

Amgen, Corporate Quality Engineering, Thousand Oaks, California, 91320, USA;

Amgen, Molecular Structure, Thousand Oaks, California, 91320, USA;

Purdue University, Depar;

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原文格式 PDF
正文语种 eng
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关键词
live validation; method precision; purity methods; uncertainty, UBCI;

机译：在线验证;方法精度;纯度方法;不确定度;UBCI;

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专利

1. Uncertainty estimates of purity measurements based on current information: Toward a "live validation" of purity methods [J] . ApostolI., KelnerD., JiangX.G., Pharmaceutical research . 2012,第12期

机译：基于当前信息的纯度测量的不确定度估计：纯度方法的“实时验证”
2. ASSAY AND PURITY EVALUATION OF CP-93,393-1 BY REVERSED-PHASE LIQUID CHROMATOGRAPHY - A SNAPSHOT OF CURRENT PRACTICES FOR LIQUID CHROMATOGRAPHY METHODS DEVELOPMENT AND VALIDATION [J] . Colgan ST, Reed RH, Dumont ML, Journal of chromatography, A: Including electrophoresis and other separation methods . 1997,第2期

机译：反相液相色谱法对CP-93,393-1的评估和纯度评估-液相色谱法开发和验证的最新实践概述
3. Nonaqueous capillary electrophoresis method for the enantiomeric purity determination of S-timolol using heptakis(2,3-di-O-methyl-6-O-sulfo)-beta-cyclodextrin: Validation using the accuracy profile strategy and estimation of uncertainty [J] . Marini RD, Servais AC, Rozet E, Journal of chromatography, A: Including electrophoresis and other separation methods . 2006,第1a2期

机译：非水毛细管电泳法使用七（2,3-二-O-甲基-6-O-磺基）-β-环糊精测定S-噻吗洛尔的对映体纯度：使用准确度分布图策略进行验证并确定不确定度
4. A Data-driven Method for Estimating Parameter Uncertainty in PMU-based Power Plant Model Validation [C] . Jacob Eisenbarth, Josh Wold IEEE Kansas Power and Energy Conference . 2020

机译：基于PMU的电厂模型验证中估计参数不确定性的数据驱动方法
5. A high-power, nanosecond, submillimeter-wave source and application to photoconductivity measurements in high-purity gallium arsenide. [D] . Smucz, Joseph Simon. 1998

机译：一种高功率，纳秒级，亚毫米波源，及其在高纯度砷化镓中的电导率测量中的应用。
6. Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a Live Validation of Purity Methods [O] . Izydor Apostol, Drew Kelner, Xinzhao Grace Jiang, -1

机译：基于当前信息的纯度测量的不确定度估计：走向纯度方法的实时验证
7. Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods [O] . Izydor Apostol, Drew Kelner, Xinzhao Grace Jiang, 2012

机译：基于当前信息的纯度测量的不确定度估计：走向纯度方法的“实时验证”
8. SOME CHEMICAL METHODS FOR THE SEPARATION OF HIGH PURITY SHORT-LIVEDnFISSION PRODUCTS [R] . R.J. Bullock, N. R. Large 1969

机译：一些分离高纯度短寿命产品的化学方法

Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

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