Validation of a near-infrared transmission spectroscopic procedure, part A: validation protocols

被引：31

作者：

Mark, H

Ritchie, GE

Roller, RW

Ciurczak, EW

Tso, C

MacDonald, SA

机构：

[1] Mark Elect, Suffern, NY 10901 USA

[2] Purdue Pharma LP, Ardsley, NY 10502 USA

[3] Eli Lilly & Co, Indianapolis, IN 46285 USA

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2002年 / 28卷 / 02期

关键词：

validation; near-infrared transmission spectroscopy; release assay; chemometrics;

D O I：

10.1016/S0731-7085(01)00567-2

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

It is possible to devise calibration and validation protocols that enable the ICH guidelines to conform to the specialized requirements of the NIR method of analysis. Some of the required characteristics of evaluation specified by the guidelines, such as accuracy and repeatability, can be applied directly, just as with any other analytical method. Other characteristics are adapted through the novel use of specialized statistics, or through the use of creative methods and procedures to match the recommendations of the guidelines to the unique and specialized requirements of the NIR method. (C) 2002 Elsevier Science B.V. All rights reserved.

引用

页码：251 / 260

页数：10