CLASSIFICATION OF ESTRADURIN(R) BATCHES - CORRELATION BETWEEN P-31 NMR AND A BIOLOGICAL DURATION TEST FOR BATCH APPROVAL

被引:10
作者
THELIN, B
LUNDSTEDT, T
LUNDGREN, R
OLSSON, A
BATRA, S
机构
[1] PHARMACIA THERAPEUT,CTR STRUCT PROPERTY OPTIMIZAT,S-20180 MALMO,SWEDEN
[2] PHARMACIA ONCOL,S-25109 HELSINGBORG,SWEDEN
[3] PHARMACIA ONCOL,S-22363 LUND,SWEDEN
关键词
D O I
10.1016/0169-7439(94)00055-N
中图分类号
TP [自动化技术、计算机技术];
学科分类号
0812 ;
摘要
The analyses used for batch approval of Estradurin(R) are a biological duration test on mice together with gel permeation chromatography. For 38 historical batches these analyses have been complemented with P-31 NMR analysis. In this work we have used multivariate methods such as principal components analysis, discriminant projections to latent structures and pattern recognition to find a correlation between the old and the new analyses for batch approval. In this way it has been possible to establish a mathematical model for approving/not approving batches of Estradurin(R) based on 31 P NMR analysis. This should make it possible to replace the animal duration test.
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页码:135 / 145
页数:11
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