• 대한예방한의학회지
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• 제18권1호
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.303.1-303.1
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• 2003

Excipients of the drug products can sometimes affect the rate and extent of drug absorption. The changes in components or composition of them can also affect the pharmacological activity. So the quantity of excipients to be changed, the new excipients and atypically large amount of commonly used excipients should be considered as bioequivalence studies. (omitted)

• 한국독성학회:학술대회논문집
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• 한국독성학회 2003년도 추계학술대회
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• pp.84-85
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• 2003

The process of drug development has seen major changes over the last two decades with the movement away from standard small molecule drug discovery programs, through computer-assisted drug design methodologies towards biotechnologically derived products. The aim of duplication of endogenously active materials to be administered exogenously has enormous impact on development practices and evaluation of safety.(omitted)

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.229-254
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• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• Journal of Pharmaceutical Investigation
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• 제36권6호
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• 한국의사학회지
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• 제27권2호
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• 한국임상약학회지
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• 제24권2호
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• pp.126-134
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• 2014

Purpose: This study was aimed to examine the financial effect of 2-tiered copayment system on annual expenditure of pharmacy benefit in the National Health Insurance (NHI) of Korea, focusing on oral antidiabetic medications. Methods: 284 oral antidiabetic products with 14 different active single ingredients listed in the National Formulary of NHI (August 2009) were assigned to tier 1 or tier 2 according to the selected criteria. 10 different combinations of coinsurance rates were selected to estimate the changes in drug expenditure cost of NHI. Results: The annual drug cost was estimated based on the drug price per unit listed in the National Formulary and the used amount of products in 2009 from the IMS Health data of Korea. In the combinations of coinsurance rate of 20% for tier 1 and 40% for tier 2, the total annual drug cost was estimated to be reduced by 1.3% in the case of no change of generic and original drug consumptions, and to be reduced by 4.3% in the case of 10% increased generic drug consumptions. Conclusion: The tiered copayment system with optimal coinsurance rates appears to be a potential strategy to reduce the financial burden of NHI in Korea by promoting the use of generic products.

• 한국임상약학회지
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• 제15권2호
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• pp.139-148
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• 2005

Appropriate drug classification is important fur rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers' ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, saff drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term Preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process fer reclassification application, are necessary.

• Journal of Microbiology and Biotechnology
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• 제27권12호
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• pp.2211-2220
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• 2017

Chlorhexidine gluconate (CHX) and benzalkonium chloride (BZK) formulations are frequently used as antiseptics in healthcare and consumer products. Burkholderia cepacia complex (BCC) contamination of pharmaceutical products could be due to the use of contaminated water in the manufacturing process, over-diluted antiseptic solutions in the product, and the use of outdated products, which in turn reduces the antimicrobial activity of CHX and BZK. To establish a "afe use" period following opening containers of CHX and BZK, we measured the antimicrobial effects of CHX ($2-10{\mu}g/ml$) and BZK ($10-50{\mu}g/ml$) at sublethal concentrations on six strains of Burkholderia cenocepacia using chemical and microbiological assays. CHX (2, 4, and $10{\mu}g/ml$) and BZK (10, 20, and $50{\mu}g/ml$) stored for 42 days at $23^{\circ}C$ showed almost the same concentration and toxicity compared with freshly prepared CHX and BZK on B. cenocepacia strains. When $5{\mu}g/ml$ CHX and $20{\mu}g/ml$ BZK were spiked to six B. cenocepacia strains with different inoculum sizes ($10^0-10^5CFU/ml$), their toxic effects were not changed for 28 days. B. cenocepacia strains in diluted CHX and BZK were detectable at concentrations up to $10^2CFU/ml$ after incubation for 28 days at $23^{\circ}C$. Although abiotic and biotic changes in the toxicity of both antiseptics were not observed, our results indicate that B. cenocepacia strains could remain viable in CHX and BZK for 28 days, which in turn, indicates the importance of control measures to monitor BCC contamination in pharmaceutical products.

• 의료법학
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• 제12권2호
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• pp.265-291
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• 2011

Changes in a drug's availability from prescription only to over-the-counter (OTC) status is of concern to physicians from both public health and individual patient perspectives. Government has generally been supportive of changes in medications from prescription(Rx) to over-the-counter (OTC) status in Korea, however, recognizing that there are both benefits and risks to any health care intervention, health care professionals are conservative in implementing changes to either the process or structure of health care. Changes in status of a drug from Rx to OTC can represent a change in both structure and process. Cost and convenience seem to be major factors in determining whether, given the choice, patients purchase a medicine over the counter or obtain it on prescription. With current arrangements, exemption from prescription charges provides an incentive to continue to obtain products on NHS prescription even when they are available over the counter. There is therefore no simple relation between the availability of over the counter medicines and the level of prescribing of deregulated products. The appropriate use of over the counter medicines-particularly those that have only recently been deregulated-places a burden of care on community pharmacists and calls for closer working relationships with general practitioners. In particular, systems for referral and for recording details of both prescribed and over the counter medicines need to be developed, and a direct route needs to be established for community pharmacists to report adverse drug reactions to over the counter products. Reclassification of prescription medicines-by making them available through pharmacies without a prescription-provides the opportunity for consumers to purchase a wider range of medicinal products without making a demand on NHS resources. There is, however, no simple relation between availability of over the counter medicines and demand for NHS prescriptions. In the late 1980s the UK government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. To explore the influence of deregulation of medicines on NHS prescribing, this article presents analyses of consumer behaviour in using medicines and prescribers' attitudes to over the counter medication and collates findings from research. Policy makers should be aware that patients' expectations in relation to OTC medicines may be in conflict with evidence-based practice.