USING ORTHOGONAL POLYNOMIAL SCORES IN SUMMARIZING AND EVALUATING LONGITUDINAL DATA COLLECTED IN PHASE-I AND PHASE-II CLINICAL-PHARMACOLOGY STUDIES

被引:6
作者
BRADSTREET, TE
机构
[1] Merck Research Laboratories, West Point, Pennsylvania
关键词
D O I
10.1002/sim.4780120703
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Orthogonal polynomial scores (OPS) is a simple, biologically meaningful approach to characterize longitudinal data in phase I and II clinical pharmacology trials. It describes average, linear, quadratic and higher order polynomial characteristics of each subject's response over time with use of composite scores computed from linear combinations of the observed data. The statistical evaluation of the composite scores is univariate. For studies with a small number of experimental units and with many repeated measures, OPS may offer advantages over the use of summary measures such as the maximum response (MAX), the time at which MAX occurred (TMAX), or the area under the response curve (AUC), and other popular approaches such as time-point-by-time-point, split-plot, and multivariate analyses.
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页码:633 / 643
页数:11
相关论文
共 34 条
[1]  
AITKEN AC, 1933, P ROY SOC EDINB, V53, P54
[2]   REGRESSION-MODELS FOR REPEATED MEASUREMENTS [J].
AITKIN, M .
BIOMETRICS, 1981, 37 (04) :831-832
[3]  
ANDERSON RL, 1942, RES B IOWA STATE COL, V297
[4]  
BRADSTREET TE, 1991, 003 MERCK SHARP DOHM
[5]  
CIMINERA JL, 1983, STATISTICAL ANAL TER
[6]  
Cochran W.G, 1957, STAT METHODS, V6th ed
[7]   APPLICATIONS OF MULTIVARIATE ANALYSIS OF VARIANCE TO REPEATED MEASUREMENTS EXPERIMENTS [J].
COLE, JWL ;
GRIZZLE, JE .
BIOMETRICS, 1966, 22 (04) :810-&
[8]   ANALYSIS OF LONGITUDINAL TIME-SERIES DATA IN TOXICOLOGY [J].
COX, C ;
CORYSLECHTA, DA .
FUNDAMENTAL AND APPLIED TOXICOLOGY, 1987, 8 (02) :159-169
[9]  
Cox D. R., 1958, PLANNING EXPT
[10]  
Crowder MJ, 2017, ANAL REPEATED MEASUR