• YAKHAK HOEJI
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• v.56 no.1
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• pp.66-69
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• 2012

This study aims to assess the aggregate contribution of new drugs to the increase in life expectancy. We constructed a panel data combining mortality data in KOSIS and a drug dataset generated by assigning new drugs listed in 2000~2009 to their respective ICD codes. We found that 10% increase in stock of new drug led to 0.13~0.27% increase in the probability of survival to age 65. Due to lack of disease-specific life table, we used indirect approach to estimate the effect of new drugs on longevity. Using ordinary least squares, the estimate of the probability of survival to age 65 (logarithm) on life expectancy for all ages was 24.92. In conclusion, the increase in life expectancy of the entire population in Korea between 2000 and 2009 resulting from NMEs is 1.95 years, which explains 46.6% of real increase in life expectancy.

• STI Policy Review
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• v.8 no.1
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• pp.62-86
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• 2017

Intellectual Property Rights (IPR) system is one of the major institutions for incentivizing innovation. However, a strong IPR regime does not necessarily encourage innovation every time. This is because a variety of factors come into play in configuring the ways the IPR system interacts with the dynamics of innovation. In the present study, we examine whether different degrees of absorptive capacity at the industry level bring about heterogeneous effects of a strong IPR regime on the innovation capability of innovators across different industries in developing country. Using the case of the 1986 IPR reform in Korea, which permitted patenting pharmaceutical products and copyrighting computer programs, we analyze the quality of patents produced by Korean applicants between 1982 and 1991. Our analysis finds no evidence that the IPR reform improved the innovation capability of innovators in the two aforementioned sectors, but rather affected their patenting behavior differently.

• Journal of Technology Innovation
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• v.21 no.2
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• pp.169-197
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• 2013

Despite many theoretical and empirical studies, general causality between IPRs system, firm technological innovation and financial performance is not clear. This study notices that the core factor to create financial performance is different by each industry. The study analyzed the effect of IPRs system on innovation and economic growth targeting 3 industries; pharmaceutical industry to which the basic track of creating performance is applied (strengthening IPRs${\rightarrow}$increasing R&D input/output${\rightarrow}$increasing sales); semiconductor industry where the relationship between stronger IPRs and R&D input/output is weak; and shipbuilding industry which has weak correlation between R&D and sales. It used panel data for 15 years since TRIPs when the patent institution in Korea reached up to the level of advanced countries, and applied the dynamic regression model which estimates the fixed effect model with difference-GMM. As a result, stronger IPRs increased R&D input/output, and financial performance in pharmaceutical industry, but has no influence on semiconductor and shipbuilding industries. That is, it is necessary to customize the construction of system and policy for strengthening IPRs by each industry, and unitary strengthening or weakening may have no significant impact on financial performance improvement in specific sectors.

• The monthly packaging world
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• s.279
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• pp.52-54
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• 2016

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• The Journal of the Korea Contents Association
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• v.21 no.11
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• pp.361-374
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• 2021

The purpose of this study is to analyze the efficiency and productivity of technological innovation activities of companies certified as innovative pharmaceutical companies by the government to diagnose their competitiveness and derive measures to strengthen them. This study collected pharmaceutical input (R&D expenditures and number of employees) and output (sale, operating profit and patent) data between 2017 and 2019 for 38 innovative pharmaceutical companies. This study analyzed them using the data envelopment analysis (DEA) method, Tobit model and the Malmquist Productivity Index (MPI). First, the DEA result of the innovative pharmaceutical companies show that between the value of the CCR model of the scale efficiency and the value of the BCC model to diagnose the internal operation efficiency is differences. Second, efficiency does not differ between corporate characteristics. Third, Tobit model shows that number of patents held have positive effects on efficiency. Forth, overall MPI is 0.89. This can be interpreted as the rate of TECI decreased 3%p and TCI has increased 4%p. The results of this study can be used as decision-making data for response strategies to improve efficiency by identifying the cause of inefficiency and presenting target values.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.373-386
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• 2022

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

• Asian Journal of Innovation and Policy
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• v.7 no.1
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• pp.103-130
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• 2018

It is generally understood that clusters are the promoters of innovation and therefore, the attention of researchers has been increasingly to discern the factors driving innovation among the firms in a cluster, especially in a high-tech cluster. In this study, we identify the variables capturing the nature of a firm that possibly impact the absorptive capacity of a firm and subsequently ascertain their impact on the degree of interactions between a firm, and other firms and associated institutions within and outside a cluster, respectively. Furthermore, we probe the influence of these interactions as a whole on firm-level innovation. The study was carried out in the context of Bengaluru, which houses the densely interconnected network of innovation-intensive high-tech manufacturing firms forming a high-tech manufacturing cluster. Data were drawn from 101 high-tech manufacturing firms belonging to electronics, machine tools, electrical and pharmaceutical industries. Based on the cluster analysis and subsequent graphical analysis on each of the three profiled clusters, it was found that size and origin of a firm have significant impact on the degree of firm's interactions. In turn, higher dynamism of firms in terms of degree of interactions led to higher innovation performance.

• Bulletin of the Korean Chemical Society
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• v.28 no.12
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• pp.2495-2497
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• 2007

• Proceedings of the Korean Society of Toxicology Conference
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• 2005.11a
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• pp.83-87
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• 2005