• YAKHAK HOEJI
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• v.57 no.3
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• pp.213-218
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• 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.

• Journal of Distribution Science
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• v.6 no.2
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• pp.41-60
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• 2008

This study examined state of local pharmaceuticals industry and investigated distribution system. The study found out associated problems as well as improvements of distribution system of local pharmaceuticals. Finally, to improve distribution system of local pharmaceuticals, the study investigated distribution system of 10 kinds of pharmaceuticals of 'J' Company being a leading local manufacturer of local pharmaceuticals, and found out improvements of the distribution system. The study collected and compiled 'J' Company's internal slips and reporting material from April 1, 2008 to July 31, 2008, and interviewed persons in charge continuously to find out state and problems of the distribution system.

• Journal of Technology Innovation
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• v.20 no.2
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• pp.135-159
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• 2012

To the analysis and discussion whether to conceptualization between the basis and LCM(Life cycle management) of patentability decisions and evergreening through research on patent application strategies and litigation cases. The Stakeholders have said that the LCM and evergreening strategies are an innovative effort to develop new pharmaceuticals, while others say that it is an effort to block generic pharmaceuticals from entering the market and permanently dominate the market by generic pharmaceuticals manufacturers or health economic perspectives. To achieve the goal of research, to discuss for conceptualization LCM and Evergreening strategies through patent application strategies for 14 pharmaceuticals for APIs and case studies for litigations. As a results, the LCM is getting patent rights for the results of research at the initial R&D stage and as such this shall be regarded as part of an effort for technology innovation. However, Evergreening is granting patent rights for the results by making high permission barrier to prevent the market entry of generic pharmaceuticals in the late development period during the pharmaceuticals development process or after their launch. This may lead to the problem of getting weak in health economic aspects and consumer welfare aspects by lowering the market accessibility of cheap generic pharmaceuticals.

• Journal of Radiation Industry
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• v.17 no.2
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• pp.127-134
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• 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.

• YAKHAK HOEJI
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• v.56 no.2
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• pp.116-125
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• 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.

• Journal of Distribution Science
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• v.5 no.2
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• pp.17-34
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• 2007

The Korean pharmaceutical industry has many pharmaceutical companies and business acquaintances, small quantity batch production and a lot of competition products having same ingredient. Under such a situation, an integrated distribution is said to be proper to lower distribution costs and deliver effectively: However, each business has different delivery conditions, timely delivery of small quantity batch order and other particular services, etc to have problems of competition of turnover increase. The study suggests measures below to lower distribution costs and to elevate sales business efficiency. First, Joint marketing of pharmaceuticals between pharmaceutical companies. Second, Joint delivery of three or less companies having similar business scales. Third, An agreement with wholesale distributors of unified distribution of pharmaceuticals being sold much. Fourthly, Wholesale distributors' pharmaceuticals distribution services. Fifthly, Cooperation of business acquaintance. In summary, the Korean pharmaceutical industry needs an integrated distribution system. Considering characteristics of the industry, however, the small pharmaceutical companies are thought to be difficult to accept the integrated distribution because complete integrated distribution may reduce sales.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 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.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.14 no.11
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• pp.5809-5818
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• 2013

This study proposes a technology portfolio analysis method for technology outsourcing of pharmaceutical cooperations by applying the concepts of 'Pipeline Soundness' and 'Patent Validity'. This study also applied the developed portfolio analysis method to a 'real world case' of Amgen's acquisition of Onyx Pharmaceuticals to prove the applicability of the method to the real world cases and investigated the validity of the acquisition affair between the two companies. The results of portfolio analysis showed that Amgen's technology portfolio will be improved by acquiring Onyx Pharmaceuticals especially in cancer field which is their main field. So we concluded that Amgen's choice of Onyx pharmaceuticals as a source of technology outsourcing was reasonable. We think that the technology portfolio analysis method developed by this study will be a valuable tool for pharmaceutical cooperations for investigating their current technology status and selecting target companies for technology outsourcing.

• Journal of Plant Biotechnology
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• v.4 no.3
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• pp.103-107
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• 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
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• v.8 no.2
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• pp.180-207
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• 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.