• Journal of the Korea Safety Management & Science
• /
• v.12 no.3
• /
• pp.37-52
• /
• 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
• /
• v.36 no.3
• /
• pp.161-167
• /
• 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
• /
• v.7 no.10
• /
• pp.875-884
• /
• 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.

• YAKHAK HOEJI
• /
• v.27 no.2
• /
• pp.139-148
• /
• 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.

• Journal of Veterinary Clinics
• /
• v.39 no.1
• /
• pp.9-15
• /
• 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.

• Journal of Pharmacopuncture
• /
• v.17 no.4
• /
• pp.36-49
• /
• 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.

• YAKHAK HOEJI
• /
• v.55 no.5
• /
• pp.411-418
• /
• 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.

• The Korean Society of Law and Medicine
• /
• v.23 no.2
• /
• pp.3-36
• /
• 2022

In order to solve the pharmaceutical kickback problem, it is needed to establish legal system that allow ways to enable pharmaceutical promotion of medicines without kickbacks as well as provide sanction those who commit illegal act. Before the National Assembly and the government focused on strengthening sanctions. As a result, in 2014, a system of suspending medical care benefits was introduced, which could inflict heavy losses on pharmaceutical companies by withdrawing target medicines from the market. However, three years after the introduction, the system was abolished in 2018, recognizing the problem that the disposition could infringe on the patients' right to access to and choice of medicines. In 2021, the National Assembly made it possible for dispositions suspending medical care benefits regarding the third violation, which remained symbolic until then, replaced with administrative fines. Although the legislator's reflective stance on the system is more than clear, the Ministry of Health and Welfare still interprets that the old law should be applied to kickbacks for the period of the law. Moreover, regarding the substitution of fines at the discretion of the Minister of Health and Welfare under the old law, the narrow standards taken under the old law seems to be maintained. In this paper, firstly pharmaceutical kickback issue, the main reason for the introduction of the system, will be explained, after that the history of introduction and abolition of the system examined and last but not least the unconstitutionality of the system and the illegality of the disposition are to be examined.

• Molecules and Cells
• /
• v.20 no.1
• /
• pp.17-29
• /
• 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
• /
• v.10 no.3
• /
• pp.167-179
• /
• 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.