• 약학회지
• /
• 제57권3호
• /
• pp.213-218
• /
• 2013

This study examines factors associated with fixed budgets for pharmaceuticals and clawback system for pharmaceutical industry in European countries. We used information from a survey held in 2005~2006 by Austrian Health Institute. Several information including pharmaceutical pricing policies, marketing conditions for pharmaceutical industry and patient' choice of drugs was collected. Five out of twenty five countries in EU were considered as countries with fixed budgets for pharmaceuticals and remaining 20 countries were considered as countries without fixed budget system. Comparisons were made for each information. Countries with fixed budgets for pharmaceuticals were more likely to have internal (or external) reference pricing system and other pricing mechanisms. In addition, they were more likely to permit pharmaceutical industry to be engaged in public advertising and information provision towards patients. They guaranteed patient participation in drug choice decisions. The countries with fixed budgets for pharmaceuticals were more likely to have conditions that enable the fixed budget system to work better compared to those without fixed budget system. Therefore, the study results imply that we need to check whether we have similar conditions to the countries that already have fixed budgets for pharmaceuticals when we want to introduce fixed budget mechanism for pharmaceuticals in Korea in the future.

• 유통과학연구
• /
• 제6권2호
• /
• pp.41-60
• /
• 2008

본 연구는 국내 제약 산업의 현황과 유통시스템을 조사하였다. 본 연구에서는 국내 제약 산업 유통시스템의 문제점을 찾아내고 그에 따른 개선점도 동시에 제시하였다. 연구는 국내 제약 산업의 유통시스템을 개선하기 위해서 국내 제약 제조의 선도기업인 'J'기업의 10가지 유통시스템을 대상으로 조사하였으며 그에 따른 유통시스템의 개선점도 찾을 수 있었다. 본 연구는 'J'기업의 2008년 4월 1일부터 7월 31일까지의 내부 보고서를 중심으로 자료를 수집하였으며 또한 지속적인 담당자 면접을 통해 유통시스템의 문제를 밝혀냈다. 그 결과 의약공급 유통시스템의 문제점으로 첫째, 직접 판매 비즈니스의 부정적 효과를 가졌고 둘째, 생계유지형의 영세한 구조였다. 셋째, 도매유통이 넘쳐나고 불법적인 거래가 보편적이었다. 이러한 문제점을 극복하기 위해서는 다음과 같은 몇 가지 대안이 시급히 마련되어야 한다. 첫째, 도매유통시스템의 역할과 기능을 더욱 강화해야 하며 둘째, 도매유통시스템 관리자의 신중한 유통시스템의 재설계가 필요하다. 셋째, 상적 유통이 더 업그레이드(upgrade) 되어야 하며 넷째, 물적 유통 또한 추가적인 업그레이드가 필요하다. 마지막으로 의약공급 유통시스템 문제 해결을 위해서 투명하고 활동적인 정보시스템이 반드시 이루어져야 함을 제시한다.

• 기술혁신연구
• /
• 제20권2호
• /
• pp.135-159
• /
• 2012

제약분야의 특허전략은 이해관계자의 입장에 따라 LCM 또는 에버그리닝으로 해석하고 있다. 오리지널 의약품 제약사는 특허전략을 기술 혁신의 노력인 LCM이라고 주장하는 반면 제네릭 의약품 제약사와 보건 당국은 오리지널 제약사의 특허전략은 값이 저렴한 제네릭 의약품의 접근성을 낮추어 항구적인 시장 지배의 목적인 에버그리닝이라고 주장하고 있다. 본 연구는 한국에서 거대시장을 형성하고 있는 오리지널 의약품의 특허출원과 특허분쟁사례를 통해 LCM과 에버그리닝을 어떻게 개념화하고 논의되어야 하는지 제시하였다. 본 사례 연구 결과 LCM은 신약개발의 새로운 기술 응용을 바탕으로 연구의 성과물을 특허전략과 연계하였다. 반면, 에버그리닝은 의약품 허가 장벽을 높이기 위한 방법중의 하나로 특허권을 활용된 것으로 판단된다. 본 연구결과를 바탕으로 이해에 따라 일방의 주장이 아닌 LCM과 에버그리닝의 개념화를 통해 차별화된 시각으로 논의를 이끌고자 한다.

• 방사선산업학회지
• /
• 제17권2호
• /
• pp.127-134
• /
• 2023

Pharmacokinetic (PK) data provide pivotal information in drug development, and they are usually first studied in the preclinical stage using various animals. However, quite often, animal PK data may not match with human PK, especially in metabolites. Thus, most regulatory agencies in the world make it mandatory to obtain metabolite information using ¹⁴C radiolabeled drug in human for small molecule drug candidates. However, such studies are expensive and time consuming and they are usually done at the end of Phase II trials using ~3.7 MBq of ¹⁴C labeled drug in a limited number of human subjects. Introduction of accelerator mass spectrometry (AMS) in this kind of study has revolutionized it. Since AMS can measure ¹⁴C level as close as natural abundance, it can quantify the amounts of ¹⁴C labeled drugs and their metabolites produced in human body that consumes less than the amount of 0.0037 MBq of ¹⁴C labeled drug, a very safe level of radioactive dose in human. Therefore, it is now possible to conduct human ¹⁴C studies safely in early clinical trials without spending hefty amount of money and time. Korea Radioisotope Center for Pharmaceuticals(KRICP) at Korea Institute of Biological and Medical Sciences(KIRAMS) has established an AMS facility in 2018, housing a 0.5MV AMS manufactured at the US National Electrostatics Corps (NEC). The AMS instrument has been validated using various standard samples that have been prepared at Lawrence Livermore National Laboratory in the US, a worldly reputable provider of AMS standards. In this paper, we present a mass balance study for acetaminophen in rats using AMS and prove that the study results are equivalent with those of literature, which shows the AMS facilities at KRICP has successfully installed and be ready to be used in the various PK studies using ¹⁴C labelled compounds for new drug development.

• 약학회지
• /
• 제56권2호
• /
• pp.116-125
• /
• 2012

Local pharmaceutical companies in Korea, which have grown focusing on domestic markets, have recently faced difficulties such as market saturation, price control policies and market-opening pressures by FTA. It seems to be an urgent issue for them to export pharmaceuticals to developed countries comprising the greater part of the global pharmaceutical market. Hence, this research was conducted to investigate and benchmark the strategies employed by India industry for the successful access to the global pharmaceutical markets. Drug policies as well as their influences on pharmaceutical market changes between India and Korea for the last 40 years have been searched and the differences have been comparatively analyzed. The pharmaceutical industry of India has the following strengths: low costs; experienced labor pool; excellent reverse-engineering skills; powerful IT; marketing capability; and established distribution network. After 2000, consolidations, M&A and alliances with domestic and multinational companies have been sharply increased in the industry of India. Indian companies unfolding both competition and cooperation with multinational corporations currently move up the value-added chain, and this enthusiastic strategy should be learned by local pharmaceutical companies.

• 유통과학연구
• /
• 제5권2호
• /
• pp.17-34
• /
• 2007

한국 제약산업은 제약회사의 수와 거래선의 수가 많고, 다품종 소량생산체제이며 동일성분의 경쟁품이 많은 실정이다. 이러한 실정 하에서 통합물류가 물류원가 절감 및 효율적인 배송에는 적절한 방안이라고 할 수 있으나 기업마다 다른 배송 조건 문제, 다품종 소량주문의 적기 배송 문제 등 회사 특유의 서비스 제공 등에 한계가 있어서 경쟁적 매출증가에 문제점이 있다 하겠다. 이와 같이 물류원가는 절감해야하고 영업효율성은 증대시켜야 하는 두 가지 문제를 두고 다음과 같은 대처방안을 제시하고자 한다. 첫째, 제약회사 간 품목 공동마케팅 실시. 둘째, 규모가 비슷한 3개 회사 이하 합동 배송실시. 셋째, 매출이 큰 제품은 도매상과 유통 일원화 협약. 넷째, 도매상이 제약 물류 서비스하도록 준비. 다섯째, 거래선의 협조 등이다. 결론적으로 한국제약산업에서 통합물류가 필요하지만 산업의 특성상 중소제약회사는 완전 통합물류는 매출이 감소할 것이라는 가정하에 그 시행이 어려울 것으로 판단되는 것이다.

• 약학회지
• /
• 제55권4호
• /
• pp.345-351
• /
• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• 한국산학기술학회논문지
• /
• 제14권11호
• /
• pp.5809-5818
• /
• 2013

본 논문에서는 '파이프라인 건전도(Pipeline Soundness)와 특허유효성(Patent Validity)개념을 적용하여 제약기업이 적합한 기술 아웃소싱 대상기업을 선정하기 위한 기술 포트폴리오 방법을 제시하고자 한다. 또한 이를 최근 발표한 Amgen의 Onyx Pharmaceuticals 인수사례에 적용하여 개발된 포트폴리오 분석방법의 실제 적용 가능성을 검토하고 사례기업의 기술아웃소싱 타당성을 분석하기로 한다. 본 연구를 통해 제시된 기술포트폴리오의 사례 적용 분석 결과 Amgen은 주력분야인 Cancer 분야의 특허유효성 개선이 시급한 것으로 분석되었으며 Onyx Pharmaceuticals의 인수를 통해 Cancer 분야의 기술포트폴리오를 안정적인 영역에 도달시킬 것으로 기대된다. Amgen의 실제 Onyx Pharmaceuticals 인수 이유 또한 Cancer 분야의 파이프라인 강화와 의약품 도입이라는 점을 고려할 때 새롭게 개발된 기술포트폴리오 분석방법이 실제사례에 잘 적용됨을 알 수 있었으며, 본 연구를 통해 개발된 기술포트폴리오 분석 방법이 제약기업의 기술현황 파악 및 인수대상기업 선정을 위한 도구로 충분히 활용 가능할 수 있을 것으로 판단된다.

• Journal of Plant Biotechnology
• /
• 제4권3호
• /
• pp.103-107
• /
• 2002

The Good Agriculture Practice (GAP) program, being established in China, is an optimal way for the sustainable utilization of the medicinal plant and animal resources. Most frequently used Chinese materia medica will be mainly produced from the GAP bases in the future. To assure the successful operation of GAP program, standard operating procedure (SOP) should be implemented for specific plants or animals. Both GAP and SOP include the requirements in many aspects from the ecological environment of cultivation place, germplasm and varieties, seedling and transplant, fertilization, irrigation, and field care, to harvest and process, package, transport and storage. As a complex system, GAP demands strong commitment from the pharmaceutical industry, local administrative involvement, long term R&D support, and years of time of development before a satisfactory result can be achieved.

• Asian Journal of Innovation and Policy
• /
• 제8권2호
• /
• pp.180-207
• /
• 2019

This article explores the historical evolutionary process of the biopharmaceutical industry of Korea, and how intentional and unintentional policy interventions have triggered the creation of the industry's system dynamics and paved the way for the generation of a few global leading products, including biosimilar, as well as next-generation therapeutics of gene and cell. The policies cover the simple technology transfer of API synthesis to overcome the endemic parasitic disease, new substance patent adoption and new drug development consortia, human resource development, various national initiatives influenced by the Human Genome Project, and venture promotion schemes. The scope and implementation tools under these policies have been aligned and refined to transform traditional fine chemical-based pharmaceuticals, to stimulate large companies' participation and to create technology-based venture companies in the biopharma business of Korea.