Parametric and non-parametric prediction intervals based phase II control charts for repeated bioassay data

被引：5

作者：

Hothorn, L. A. ^{[1
]}

Gerhard, D. ^{[1
]}

Hofmann, M. ^{[2
]}

机构：

[1] Leibniz Univ Hannover, Inst Biostat, D-30419 Hannover, Germany

[2] Novartis Pharma AG, Biotechnol Dev, ARD, CH-4057 Basel, Switzerland

来源：

BIOLOGICALS | 2009年 / 37卷 / 05期

关键词：

Statistical quality control; Phase II control charts; Non-parametric control charts; Bioassay; LIMITS;

D O I：

10.1016/j.biologicals.2009.07.001

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Quality control for repeated bioassay runs can be performed by phase H control charts, well-known from industrial quality control. The value of interest is the potency, of which a single value per run is available. Parametric and non-parametric prediction intervals are described to estimate quality control intervals for future re-test runs. Violations against the normal distribution occur in real data frequently, particularly outliers. The non-parametric prediction intervals are limited to not too small sample sizes in both the historical and future sampling phases. Therefore, robust prediction intervals based on winsorization are proposed. R-functions for all prediction intervals are provided. (C) 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

引用

页码：323 / 330

页数：8

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