A ruggedness test strategy for procedure related factors: experimental set-up and interpretation

被引:30
作者
Vander Heyden, Y [1 ]
Questier, F [1 ]
Massart, DL [1 ]
机构
[1] Vrije Univ Brussel, ChemoAC, Inst Pharmaceut, B-1090 Brussels, Belgium
关键词
ruggedness test strategy; method validation; experimental design; factorial design; Plackett-Burman design;
D O I
10.1016/S0731-7085(97)00196-9
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A strategy to perform ruggedness tests for mainly procedure related factors is described. The different steps in the set-up of the experiments and in the interpretation of the results are given. The described strategy is based on a number of case studies and allows a statistical interpretation of the significance of the effects. It was implemented in a software tool. This original strategy was completed with a number of minimal screening designs which reduce the number of experiments to perform, but in consequence only allow a limited or no statistical interpretation of the effects. Some of the minimal designs are expandable to designs with characteristics similar to those of the original strategy. (C) 1998 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:153 / 168
页数:16
相关论文
共 29 条
[1]  
[Anonymous], CHEMOMETRICS EXPT DE
[2]  
[Anonymous], 1994, 57253 ISO
[3]  
[Anonymous], STP PHARM PRATIQUES
[4]   Determination of the enantiomeric purity of dexfenfluramine by capillary electrophoresis: Use of a Plackett-Burman design for the optimization of the separation [J].
Boonkerd, S ;
Detaevernier, MR ;
Heyden, YV ;
Vindevogel, J ;
Michotte, Y .
JOURNAL OF CHROMATOGRAPHY A, 1996, 736 (1-2) :281-289
[5]   SOME SYSTEMATIC SUPERSATURATED DESIGNS [J].
BOOTH, KHV ;
COX, DR .
TECHNOMETRICS, 1962, 4 (04) :489-&
[6]  
Box G.E.P., 1978, STATISTICS EXPT, P306
[7]  
DEMING SN, 1993, DATA HANDLING SCI TE, V11, P317
[8]  
GOUPY JL, 1993, METHODS EXPT DESIGN, P159
[9]  
LI SFY, 1992, J CHROMATOGRAPHY LIB, V52, P316
[10]   A NEW CLASS OF SUPERSATURATED DESIGNS [J].
LIN, DKJ .
TECHNOMETRICS, 1993, 35 (01) :28-31