Evidence map›Paper›PMID 29191177›Full record

ArticleBMC medical research methodology2017

Performance comparison of first-order conditional estimation with interaction and Bayesian estimation methods for estimating the population parameters and its distribution from data sets with a low number of subjects.

Sudeep Pradhan, Byungjeong Song, Jaeyeon Lee, Jung-Woo Chae, Kyung Im Kim, Hyun-Moon Back, Nayoung Han, Kwang-Il Kwon, Hwi-Yeol Yun

Abstract readComparative Study
In one paragraph

Article in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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2citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Sudeep PradhanCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea.
Byungjeong SongCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea.
Jaeyeon LeeAcademic Planning Department, Yonsung Fine Chemicals, Suwon, 16675, Republic of Korea.
Jung-Woo ChaeDepartment of Pharmacy, Faculty of Science, National University of Singapore, Singapore, 117543, Singapore.
Kyung Im KimCollege of Pharmacy, Korea University, Sejong, 30019, Republic of Korea.
Hyun-Moon BackCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea.
Nayoung HanCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea.
Kwang-Il KwonCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea. kwon@cnu.ac.kr.
Hwi-Yeol YunCollege of Pharmacy, Chungnam National University, Daejeon, 34134, Republic of Korea. hyyun@cnu.ac.kr.

Funding

Korea Health Industry Development Institute HI17C0927National Research Foundation of Korea 2009-0093815National Research Foundation of Korea 2014R1A1A1006006
6 · The paper itself

Abstract

backgroundExploratory preclinical, as well as clinical trials, may involve a small number of patients, making it difficult to calculate and analyze the pharmacokinetic (PK) parameters, especially if the PK parameters show very high inter-individual variability (IIV). In this study, the performance of a classical first-order conditional estimation with interaction (FOCE-I) and expectation maximization (EM)-based Markov chain Monte Carlo Bayesian (BAYES) estimation methods were compared for estimating the population parameters and its distribution from data sets having a low number of subjects.

methodsIn this study, 100 data sets were simulated with eight sampling points for each subject and with six different levels of IIV (5%, 10%, 20%, 30%, 50%, and 80%) in their PK parameter distribution. A stochastic simulation and estimation (SSE) study was performed to simultaneously simulate data sets and estimate the parameters using four different methods: FOCE-I only, BAYES(C) (FOCE-I and BAYES composite method), BAYES(F) (BAYES with all true initial parameters and fixed ω

resultsThe rRMSE and REE values of all parameter (fixed effect and random effect) estimates showed that all four methods performed equally at the lower IIV levels, while the FOCE-I method performed better than other EM-based methods at higher IIV levels (greater than 30%). In general, estimates of random-effect parameters showed significant bias and imprecision, irrespective of the estimation method used and the level of IIV. Similar performance of the estimation methods was observed with theophylline dataset.

conclusionsThe classical FOCE-I method appeared to estimate the PK parameters more reliably than the BAYES method when using a simple model and data containing only a few subjects. EM-based estimation methods can be considered for adapting to the specific needs of a modeling project at later steps of modeling.

Indexed as

AlgorithmsBayes TheoremData Interpretation, StatisticalDemographyHumansMarkov ChainsMonte Carlo MethodStochastic ProcessesEstimation methodsFew subjectsFirst-order conditional estimation with interactionMarkov chain Monte Carlo BayesianNONMEM

Identifiers

PMID29191177
PMCPMC5709938

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