Transl Clin Pharmacol.  2019 Dec;27(4):149-154. 10.12793/tcp.2019.27.4.149.

A review of three years' experience of the first pharmacometrics company in Korea

• Lee SJ
• Jeon S

• KMID: 2467969
• DOI: http://doi.org/10.12793/tcp.2019.27.4.149

Abstract

As the pharmaceutical industry in Korea is reaching the golden era of drug discovery due to increased investments in research and development and government funds, the need for a more efficient tool for the quantitative analysis has emerged. Therefore, the demand for pharmacometrics (PMx) consultancy services increased. Higher quality service suitable for regulatory submission and out-licensing deals were desired. In this analysis, we compiled and summarized 3 years of experiences of Q-fitter, the first PMx consultancy service company providing PMx analysis to the pharmaceutical industry in Korea. The projects were organized by companies, company types, indications, therapeutic areas, drug development stages, purposes, and scope of services. Within each category, we subcategorized the sections and assessed proportions and a year-over-year trend. As a result, we observed an increase in the number of projects in an average of ~170% per year, with the most frequent types of companies collaborated being the domestic pharmaceutical companies. Among the projects, ~72% involved modeling and simulation using population pharmacokinetic (PK) models, and the other included non-compartmental analysis (NCA), drug-drug interaction (DDI) prediction, and interpretation of the modeling results. The most sought-after purpose in PMx analysis was first-in-human (FIH) dose prediction followed by PK analysis, next clinical trial prediction, and scenario-based simulation. Oncology has been the top therapeutic area of interest every year consisting of ~38% of total projects, followed by Neurology (~13%). From this review, we were able to characterize the PMx service needs and spot the trend of current PMx practices in Korea.

Keyword

Modeling; Pharmaceutical industry; Pharmacokinetic/pharmacodynamic; Pharmacometrics; Simulation

MeSH Terms

Drug Discovery
Drug Industry
Financial Management
Investments
Korea*
Neurology

Figure

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  Figure 1 Purposes of PMx services projects (2016–2019). The purposes are divided into 8 different subcategories.

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  Figure 2 The yearly trend of purposes of PMx service projects (2016–2017 vs. 2018 vs. 2019). The number of projects per each year by each subcategory is outlined.

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  Figure 3 Drug development stages of PMx service projects (2016–2019). The purposes are divided into 7 different subcategories.

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  Figure 4 The yearly trend of drug development stages of PMx services projects (2016–2017 vs. 2018 vs. 2019). The number of projects per each year by each subcategory is outlined.

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  Figure 5 Therapeutic areas of PMx service projects (2016–2019). The therapeutic areas are divided into 11 different subcategories.

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  Figure 6 The yearly trend of therapeutic areas of PMx services projects (2016–2017 vs. 2018 vs. 2019). The number of projects per each year by each subcategory is outlined.

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  Figure 7 Types of the companies of PMx service projects (2016–2019). The types of companies are divided into 4 different subcategories.

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