• 약학회지
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• 제56권1호
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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.

• 기술혁신연구
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• 제21권2호
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• pp.169-197
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• 2013

다수의 이론적, 실증적 연구에도 불구하고 지식재산권 제도와 기업의 기술혁신 및 경영성과간의 일반적 인과관계는 명확하지 않다. 본 연구는 산업별 기업 경영성과의 핵심 요인이 상이하다는 점에 주목한다. 이를 바탕으로 (1)지식재산권 강화${\rightarrow}$연구개발의 투입/산출 증가${\rightarrow}$매출증가로 이어지는 기본 성과창출경로가 작용하는 제약 산업, (2)지식재산권 강화와 연구개발 투입/산출간 관계가 약한 반도체산업, (3)연구개발과 매출 간 관계가 약한 조선 산업까지 세 산업을 대상으로 지식재산권 제도가 기술혁신과 경영성과에 미치는 영향을 분석했다. 한국의 특허제도가 선진국 수준에 이른 TRIPs 이후 15년간의 대기업 패널 데이터를 사용했으며, 고정효과모형을 차분 GMM으로 추정해 동태적 인과관계를 분석했다. 결과적으로, 지식재산권 강화가 제약 산업에서는 연구개발의 투입/산출 및 경영성과를 모두 증가시켰지만, 반도체-조선 산업에서는 영향을 미치지 못하는 것으로 나타났다. 즉, 지식재산권 강화를 위한 제도 구축과 정책은 산업별로 맞춤화될 필요가 있으며, 획일적인 강화/약화는 특정 산업의 경영성과 제고에 유의미한 영향을 미치지 못한다.

• STI Policy Review
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• 제8권1호
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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.

• 월간포장계
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• 통권279호
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• pp.52-54
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• 2016

• Journal of Pharmaceutical Investigation
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• 제37권6호
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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.

• 한국콘텐츠학회논문지
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• 제21권11호
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• pp.361-374
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• 2021

본 연구의 목적은 혁신형제약기업 인증 기업을 대상으로, 기술혁신활동에 대한 효율성과 생산성을 분석하여 경쟁력을 진단하고 강화 방안을 도출하는 것이다. 이를 위해 38개 혁신형제약기업에 대한 2017~2019년 동안의 투입(연구개발비, 종업원 수) 및 산출(매출, 영업이익, 특허) 데이터를 수집하여, DEA, Tobit 및 MPI를 실시하였다. 그 결과 첫째, 혁신형제약기업의 DEA 결과는 규모의 효율성을 보여주는 CCR 모형 값과 내부 운영 효율성을 나타내는 BCC 모형 값 간에 차이가 있었다. 둘째, 효율성은 기업의 특성에 따라 다르지 않았다. 셋째, Tobit 모형은 보유특허수가 효율성에 긍정적인 영향을 미치는 것으로 나타났다. 넷째, 전체 MPI는 0.89로, 이는 TECI가 3%p 감소하고 TCI가 4%p 증가한 것으로 해석할 수 있다. 본 연구의 결과는 비효율의 원인을 규명하고 목표값을 제시하여 효율성 향상을 위한 대응전략을 위한 의사결정 자료로 활용할 수 있다.

• 품질경영학회지
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• 제50권3호
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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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• 제7권1호
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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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• 제28권12호
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• pp.2495-2497
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• 2007

• 한국독성학회:학술대회논문집
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• 한국독성학회 2005년도 추계학술대회
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• pp.83-87
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• 2005