• 대한안전경영과학회지
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• 제12권3호
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Journal of Pharmaceutical Investigation
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• 제36권3호
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• pp.161-167
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• 2006

The objective of this study was to investigate the dissolution patterns of variety of orally administered drug products available on the market. It aimed to understand their dissolution behaviors on the basis of the biopharmaceutics classification system (BCS) concept. On the tenets of BCS, several active pharmaceutical ingredients were selected: fluoxetine hydrochloride (class I), naproxen sodium (class ll), pyridostigmine bromide (class III), furosemide (class IV) and simvastatin (class IV). Typical dissolution media used in this study were pH 1.2, pH 4 & 6.8 phosphate buffers, and water. In cases, particular dissolution media specified in the KP and/or USP were used. Dissolution patterns of fluoxetine hydrochloride and pyridostigmine bromide products were characterized by their rapid release In addition, their dissolution characteristics were relatively unaffected by the type of a dissolution medium. Similar dissolution patterns were observed with pH 1.2, pH 4 & 6.8 phosphate buffers and water. By sharp contrast, poor dissolution patterns were noticed with naproxen sodium products, when pH 1.2 and pH 4 phosphate buffer were used. Improvements in its dissolution were achieved by switching the dissolution media to pH 6.8 phosphate buffer or water. Unsatisfactory dissolution data also were observed with a simvastatin product, when it was subject to dissolution tests by use of a surfactant-free pH 1.2, pH 4 & 6.8 phosphate buffers and water. All the release patterns reported in this study were best understood when BCS concepts were implemented. Our results demonstrated that a BCS-based drug classification should be considered first to choose a dissolution test/method and set up dissolution specification.

• The Journal of Asian Finance, Economics and Business
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• 제7권10호
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• pp.875-884
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• 2020

Thailand has a rapidly growing pharmaceutical sector, which is the eighth largest in the Asia-Pacific region and one of the largest and most developed among the Association of Southeast Asian Nations (ASEAN) countries. This study examines how to provide the most appropriate approach to enhance Thailand's pharmaceutical services to dispense medicine to end consumers. The main objective is to determine the most appropriate corporate image for Thai Pharmacy Retail Stores (PRSs) for entering the ASEAN market community. An exploratory mixed-method design characterized by qualitative and quantitative phases of data collection and analysis and the linking of data from these two separate data strands was adopted to conduct an in-depth interview with pharmacists and the owner of pharmacy retail stores as well as 405 respondents who had visited a pharmacy retail store and interacted with pharmacists during the previous year. The multiple linear regression (MLR) was applied to analyze the relative influences of perceived service quality and the cultural dimension on the corporate image. Findings reveal that the perceived service quality and cultural dimension contribute 50% towards the corporate image, and the perceived service quality had more effect than cultural dimension. This study mainly focuses on PRSs in Thailand, while the findings show other analyses concerning how to successfully create and promote an effective PRS image for ASEAN markets.

• 약학회지
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• 제27권2호
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• pp.139-148
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• 1983

The neutralizing capacities of the antacids, which are frequently used in Korean market, were evaluated in vitro by the methods of Resset and Rice, Fordtran and Collyns, and modified Beekman, respectively. The antacids used in the study are two kinds, the one is preparations from Seoul National University Hospital and the other is products from pharmaceutical companies, and their components are aluminum phosphate, aluminum hydroxide, magnesium aluminum hydroxide, magnesium hydroxide, basic aluminum sucrose sulfate and $2MgO{\times}Al_{2}O_{3}{\times}SiO_{3}$, etc. The hospital preparations, DMC and MAC powders, showed most powerful and sustained neutralizing capacities, i.e. they maintained the pH range from 5 to 8 for 60min, Whereas pharmaceutical products, aluminum hydroxide gel containing magnesium hydroxide and magnesium aluminum hydroxide gel exhibited a moderate capacities, i.e pH ranged from 3 to 6, and aluminum phosphate, $2MgO{\times}Al_{2}O_{3}{\times}SiO_{2}$ and basic aluminum sucrose sulfate displayed a weak activity, pH ranged from 2 to 3. When the therapeutic doses of aluminum hydroxide gel containing magnesium hydroxide and magnesium aluminum hydroxide gel were divided into 2 doses and each dose was used at the interval of 30min., the divided doses kept more prolonged higher pH than the single therapeutic dose. Milliequivalents of neutralizing capacities of each antacid were measured by the method of Fordtran and Collyns. The milliequivalents per 1ml of aluminum hydroxide gel, aluminum hydroxide gel containing magnesium hydroxide, magnesium aluminum hydroxide gel and aluminum phosphate were 2.87, 2.86, 2.57, and 0.67, respectively. The milliequivalents per 100mg of preparations, i.e. MAC powder, dried aluminum hydroxidgel, DMC powder, 2MgO, $Al_{2}O_{3}$. $SiO_{2}$, magnesium aluminum hydroxide and basic aluminum sucrose sulfate were 1.91, 1.68 1.63, 1.45, 1.44, and 0.44, respectively.

• 한국임상수의학회지
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• 제39권1호
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• pp.9-15
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• 2022

As more veterinary clinics become specialized with the growth of the companion animal market, an increasing number of veterinary clinics perform orthopedic surgery and use orthopedic products, some of which are defective and have side effects. Thus, the present study aimed to prepare fundamental data for the revision and development of manufacturing standards for these products in order to prevent their side effects. We conducted a survey targeting veterinary clinics as consumers and medical device companies as suppliers. Veterinary clinics were surveyed via offline and online methods; 320 clinics that offered orthopedic surgery and approximately 4,000 veterinary clinics that were registered in the Korean Veterinary Medical Association were targeted, and 153 veterinary clinics responded to the survey. The survey for medical device companies, was performed online, targeting 29 companies; 14 companies responded. The number of side effects of orthopedic products was higher in animal orthopedic products than in those for human use. Many consumers tended to suspect that side effects were caused by product defects. To resolve side effects after using orthopedic products, consumers mostly underwent reoperation. Meanwhile, some severe cases proceeded to legal disputes. Similarly, medical device companies, or the suppliers, responded that most side effects occurred in veterinary orthopedic products and that product defects and mistakes in use were the causes. As for most of the follow-up actions for side effects, these companies either reported the issue to those in charge or analyzed and resolved the issues themselves. Therefore, to develop quality products, suppliers should be provided with clear standards for the production, and information disclosure and a report system for side effects should be particularly established to gain consumers' trust regarding the safety of these products.

• 대한약침학회지
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• 제17권4호
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• pp.36-49
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• 2014

Objectives: Quercetin and curcuminoids are important bioactive compounds found in many herbs. Previously reported high performance liquid chromatography ultraviolet (HPLC-UV) methods for the detection of quercetin and curcuminoids have several disadvantages, including unsatisfactory separation times and lack of validation according the standard guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Methods: A rapid, specific, reversed phase, HPLC-UV method with an isocratic elution of acetonitrile and 2% v/v acetic acid (40% : 60% v/v) (pH 2.6) at a flow rate of 1.3 mL/minutes, a column temperature of $35^{\circ}C$, and ultraviolet (UV) detection at 370 nm was developed. The method was validated and applied to the quantification of different types of market available Chinese medicine extracts, pills and tablets. Results: The method allowed simultaneous determination of quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin in the concentration ranges of $0.00488-200{\mu}g/mL$, $0.625-320{\mu}g/mL$, $0.07813-320{\mu}g/mL$ and $0.03906-320{\mu}g/mL$, respectively. The limits of detection and quantification, respectively, were 0.00488 and $0.03906{\mu}g/mL$ for quercetin, 0.62500 and $2.50000{\mu}g/mL$ for bisdemethoxycurcumin, 0.07813 and $0.31250{\mu}g/mL$ for demethoxycurcumin, and 0.03906 and $0.07813{\mu}g/mL$ for curcumin. The percent relative intra day standard deviation (% RSD) values were $0.432-0.806{\mu}g/mL$, $0.576-0.723{\mu}g/mL$, $0.635-0.752{\mu}g/mL$ and $0.655-0.732{\mu}g/mL$ for quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin, respectively, and those for intra day precision were $0.323-0.968{\mu}g/mL$, $0.805-0.854{\mu}g/mL$, $0.078-0.844{\mu}g/mL$ and $0.275-0.829{\mu}g/mL$, respectively. The intra day accuracies were 99.589%-100.821%, 98.588%-101.084%, 9.289%-100.88%, and 98.292%-101.022% for quercetin, bisdemethoxycurcumin, demethoxycurcumin and curcumin, respectively, and the inter day accuracy were 99.665%-103.06%, 97.669%-103.513%, 99.569%-103.617%, and 97.929%-103.606%, respectively. Conclusion: The method was found to be simple, accurate and precise and is recommended for routine quality control analysis of commercial Chinese medicine products containing the flour flavonoids as their principle components in the extracts.

• 약학회지
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• 제55권5호
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• pp.411-418
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• 2011

The dissolution test method and an analytical procedure by HPLC were developed and validated for nafronyl oxalate capsules and tramadol hydrochloride capsules. These drugs were not yet characterized by the dissolution specifications in the Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for nafronyl oxalate capsules was carried out under sink conditions as follows: dissolution medium phosphate buffer pH 6.8, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 80% of its label amount was released within 30 min in this method. Also the dissolution test for tramadol hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 15 min in this method. The dissolution samples were analyzed with a validated HPLC analytical procedure. The analytical methodology showed acceptable values in terms of specificity, linearity, precision and accuracy. The dissolution test methods described above were adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of nafronyl oxalate capsules and tramadol hydrochloride capsules. Furthermore, the outcomes of this study were expected to help create an environment where safe and high quality drugs would be distributed on the domestic market making contributions to advancing public health.

• 의료법학
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• 제23권2호
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• pp.3-36
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• 2022

의약품 리베이트 문제를 해결하기 위해서는 위법행위를 한 자를 제재하는 것과 함께 리베이트를 하지 않아도 의약품 판매촉진 경쟁에서 이길 수 있는 방법을 제공하는 구조적인 법 제도 개선이 필요하다. 이전에 국회와 정부는 제재를 강화하는 방안에만 노력을 기울였다. 그 결과 2014년 처분 대상 의약품을 시장에서 퇴출시킴으로써 제약회사에게 막대한 손실을 입힐 수 있는 제재 방법인 급여정지 제도를 도입하였다. 하지만 제도 도입 3년 만에 급여정지 처분이 환자의 의약품 접근권을 침해한다는 문제를 인식하고 2018년에 급히 급여정지 제도를 폐지하였다. 국회는 2021년 상징적으로 남아 있던 3차 위반 시 급여정지 처분도 모두 과징금 갈음이 되도록 입법을 하였다. 이렇게 급여정지 처분에 대한 입법자의 반성적 입장이 분명하지만 보건복지부는 구법 기간 동안의 리베이트에 대해서는 구법 상 급여정지 처분을 하여야 한다는 법 해석을 하고 있다. 구법 상 보건복지부 재량으로 되어 있는 과징금 갈음에 대해서도 법 개정 전 구법 하에서 취했던 좁은 기준을 그대로 유지하고 적극적으로 재량을 행사하지 않겠다는 입장이다. 본고에서는 급여정지 제도 도입의 이유가 된 의약품 리베이트 문제를 개관하고 급여정지 제도의 도입, 폐지 경위를 살핀 후 급여정지 처분의 위헌적 요소와 급여정지 처분의 위법성을 검토한다.

• Molecules and Cells
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• 제20권1호
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• pp.17-29
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• 2005

Therapeutic antibodies represent one of the fastest growing areas of the pharmaceutical industry. There are currently 19 monoclonal antibodies in the market that have been approved by the FDA and over 150 in clinical developments. Driven by innovation and technological developments, therapeutic antibodies are the second largest biopharmaceutical product category after vaccines. Antibodies have been engineered by a variety of methods to suit a particular therapeutic use. This review describes the structural and functional characteristics of antibody and the antibody engineering for the generation and optimization of therapeutic antibodies.

• Biotechnology and Bioprocess Engineering:BBE
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• 제10권3호
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• pp.167-179
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• 2005

Chiral epoxides are highly valuable intermediates, used for the synthesis of pharmaceutical drugs and agrochemicals. They have broad scope of market demand because of their applications. A major challenge in modern organic chemistry is to generate such compounds in high yields, with high stereo- and regio-selectivities. Epoxide hydrolases (EH) are promising biocatalysts for the preparation of chiral epoxides and vicinal diols. They exhibit high enantioselectivity for their substrates, and can be effectively used in the resolution of racemic epoxides through enantioselective hydrolysis. The selective hydrolysis of a racemic epoxide can produce both the corresponding diols and the unreacted epoxides with high enantiomeric excess (ee) value. The potential of microbial EH to produce chiral epoxides and vicinal diol has prompted researchers to explore their use in the synthesis of epoxides and diols with high ee values.