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Implementation and Evaluation of the SAEM Algorithm for Longitudinal Ordered Categorical Data with an Illustration in Pharmacokinetics–Pharmacodynamics

Content Provider	Springer Nature Link
Author	Savic, Radojka M. Mentré, France Lavielle, Marc
Copyright Year	2010
Abstract	Analysis of longitudinal ordered categorical efficacy or safety data in clinical trials using mixed models is increasingly performed. However, algorithms available for maximum likelihood estimation using an approximation of the likelihood integral, including LAPLACE approach, may give rise to biased parameter estimates. The SAEM algorithm is an efficient and powerful tool in the analysis of continuous/count mixed models. The aim of this study was to implement and investigate the performance of the SAEM algorithm for longitudinal categorical data. The SAEM algorithm is extended for parameter estimation in ordered categorical mixed models together with an estimation of the Fisher information matrix and the likelihood. We used Monte Carlo simulations using previously published scenarios evaluated with NONMEM. Accuracy and precision in parameter estimation and standard error estimates were assessed in terms of relative bias and root mean square error. This algorithm was illustrated on the simultaneous analysis of pharmacokinetic and discretized efficacy data obtained after a single dose of warfarin in healthy volunteers. The new SAEM algorithm is implemented in MONOLIX 3.1 for discrete mixed models. The analyses show that for parameter estimation, the relative bias is low for both fixed effects and variance components in all models studied. Estimated and empirical standard errors are similar. The warfarin example illustrates how simple and rapid it is to analyze simultaneously continuous and discrete data with MONOLIX 3.1. The SAEM algorithm is extended for analysis of longitudinal categorical data. It provides accurate estimates parameters and standard errors. The estimation is fast and stable.
Starting Page	44
Ending Page	53
Page Count	10
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	13
Issue Number	1
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2010-11-11
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	categorical data mixed models MONOLIX proportional odds model SAEM Pharmacy Biotechnology Biochemistry Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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Title: Implementation and Evaluation of the SAEM algorithm for longitudinal ordered categorical data with an illustration in pharmacokinetics-pharmacodynamics ” (2011)

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Implementation and Evaluation of the SAEM Algorithm for Longitudinal Ordered Categorical Data with an Illustration in Pharmacokinetics–Pharmacodynamics