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Statistical Considerations for Comparative Assessment of Quality Attributes
Statistics in Biopharmaceutical Research ( IF 1.8 ) Pub Date : 2020-06-08 , DOI: 10.1080/19466315.2020.1767194
Richard K. Burdick 1
Affiliation  

Abstract

The objective of this article is to provide a list of considerations when selecting a statistical method for demonstrating comparability. Two approaches are proposed and evaluated against these considerations. One approach applies a quality range and the second approach is based on the concept of “acceptability.”



中文翻译:

质量属性比较评估的统计考虑

摘要

本文的目的是在选择用于证明可比性的统计方法时提供一系列注意事项。针对这些考虑,提出并评估了两种方法。一种方法应用质量范围,第二种方法基于“可接受性”的概念。

更新日期:2020-06-08
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