Using orthogonal polynomial scores in summarizing and evaluating longitudinal data collected in phase I and II clinical pharmacology studies.

Abstract:

: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.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Bradstreet TE

doi

10.1002/sim.4780120703

subject

Has Abstract

pub_date

1993-04-15 00:00:00

pages

633-43

issue

7

eissn

0277-6715

issn

1097-0258

journal_volume

12

pub_type

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