• East Asian Economic Review
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• 제24권2호
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• pp.127-164
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• 2020

We perform an econometric assessment of the role that pharmaceutical innovation-the introduction and use of new drugs-has played in improving the health of Koreans, by investigating whether diseases for which more new drugs were launched had larger subsequent increases in longevity and smaller subsequent increases in hospitalization. Drugs launched during 1993-2012 are estimated to have increased mean age at death from all diseases by 1.71 years between 1995 and 2015 and 1.09 years between 2005 and 2015. We also estimate that new drugs increased the five-year relative survival rate from all cancers combined by 23.2 percentage points-78.5% of the total increase-between 1993-1995 and 2011-2015, and that new drugs launched during 2008-2010 reduced the number of hospital days in 2017 by 13.0 million. If the drugs launched during 2003-2012 had had no effect on other medical expenditure in 2015, the cost per life-year gained would not have exceeded 6332 USD. Therefore, even if we ignore the effect of new drugs on hospital utilization, the drugs launched during 2003-2012 were very cost-effective, overall. When reduced hospital utilization is accounted for, the evidence indicates that, in the long run, pharmaceutical innovation was cost-saving as well as life-year saving.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1998년도 Proceedings of UNESCO-internetwork Cooperative Regional Seminar and Workshop on Bioassay Guided Isolation of Bioactive Substances from Natural Products and Microbial Products
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• pp.114-117
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• 1998

Chinese traditional drugs have a long history to be used in clinics to treat various diseases and are confirmed to be effective approach through thousands of years of medical practice. Therefore, as a common understanding, the drug development from traditional Chinese medicines could be considered as a “shortcut” way with less blindness and more saving of time and money since development of new Chinese drugs has a different approach from that of western new drugs. Firstly, Chinese new drug development can be simplified as “from men to animal” process rather than “from animal to men” in western medicines. Hence the successful rate would be higher. Secondly, the original drugs or prescriptions from which the new drugs are planned to develop have been known what symptoms they are indicated for. Therefore, the developing procedure is actually a refine process with much less blindness than that of western drugs.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1995년도 춘계학술대회
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• pp.124-124
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• 1995

Cisplatinum is often effective in cancer treatment, but potent nephrotoxicity limits its clinical use. We have, therefore, developed new anticancer drugs that contain platinum. We have synthesized six new platinum compounds based on Figure 1. Drugs were initially administrated at 5${\times}$10$\^$-4/M with 48 hours exposure in monolayer cultures of primary rabbit proximal tubular cells and human renal cortical cells with the M.T.T. endpoint to measure toxicity. Drug concentrations of 10$\^$-3/M, 10$\^$-4/M, and 10$\^$-5/M with 72 hours exposure were used for human renal cortical tissues in 7 weeks histoculture with toxicity measured by the glucose-consumption endpoint. From these studies, we determined that the new platinum drugs have lower nephrotoxicity than cisplatinum. Drugs D, E, and H. have lower nephrotoxicity than the other new drugs. We are currently measuring the anticancer efficacy of drugs D, E, and H.

• 한국재난정보학회 논문집
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• 제19권2호
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• pp.270-279
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• 2023

연구목적: 이 연구는 최근 급증하고 있는 신종 마약류에 대하여 살펴보고, 이를 근절할 수 있는 대응방안을 제시하기 위한 목적의 연구이다. 연구방법:연구의 목적을 달성하기 위하여 관련 분야의 선행연구 및 통계, 해외 자료 등을 이용하여 신종 마약류에 대한 문제점을 파악하고 대응방안을 제시하고자 한다. 연구결과: 과거에 비해 국내로 마약류 투약·유통·제조하는 마약류 범죄자의 적발 사례가 급격하게 증하고 있는 모습을 보이고 있다. 2021년 마약류 관련 통계자료를 살펴보면, 2021년에는 전년대비 감소하는 모습을 보였으나, 적발되는 마약량은 세배 이상 증가한 모습을 보이고 있으며, 외국인 마약사범이 급벽하게 증가하고 있고, 마약류 사범의 연령대가 감소하는 우려스러운 모습을 보여주었다. 이러한 결과는 신종 마약류 확산이 크게 영향을 끼치고 있는데, 특히 펜타닐과, 야바, 까뜨, 크라톰 등과 같은 신종마약류의 확산과 새로운 향정신성의 의약품 및 대마관련 물품의 영향이라고 보여진다. 결론: 신종마약류의 확산에 따라 임시마약류 지정방식을 간소화하고 외국인 마약사범의 단속을 확대하고, 관세청 및 식약청 등 관련 기관과의 협력을 강화함과 동시에 마약사범에 대한 강력한 처벌을 통하여 신종마약류에 대한 대응을 강화하는 방안을 제안해 본다.

• 대한한의학원전학회지
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• 제27권4호
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• 대한약침학회지
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• 제19권1호
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• pp.7-15
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• 2016

Objectives: Malaria has been a major global health problem in recent times with increasing mortality. Current treatment methods include parasiticidal drugs and vaccinations. However, resistance among malarial parasites to the existing drugs has emerged as a significant area of concern in anti-malarial drug design. Researchers are now desperately looking for new targets to develop anti-malarials drug which is more target specific. Malarial parasites harbor a plastid-like organelle known as the 'apicoplast', which is thought to provide an exciting new outlook for the development of drugs to be used against the parasite. This review elaborates on the current state of development of novel compounds targeted againstemerging malaria parasites. Methods: The apicoplast, originates by an endosymbiotic process, contains a range of metabolic pathways and housekeeping processes that differ from the host body and thereby presents ideal strategies for anti-malarial drug therapy. Drugs are designed by targeting the unique mechanism of the apicoplasts genetic machinery. Several anabolic and catabolic processes, like fatty acid, isopenetyl diphosphate and heme synthess in this organelle, have also been targeted by drugs. Results: Apicoplasts offer exciting opportunities for the development of malarial treatment specific drugs have been found to act by disrupting this organelle's function, which wouldimpede the survival of the parasite. Conclusion: Recent advanced drugs, their modes of action, and their advantages in the treatment of malaria by using apicoplasts as a target are discussed in this review which thought to be very useful in desigining anti-malarial drugs. Targetting the genetic machinery of apicoplast shows a great advantange regarding anti-malarial drug design. Critical knowledge of these new drugs would give a healthier understanding for deciphering the mechanism of action of anti-malarial drugs when targeting apicoplasts to overcome drug resistance.

• 한국임상약학회지
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• 제30권3호
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• pp.177-184
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• 2020

Background & objective: The Korean government has expanded its benefit coverage to enhance patients' access to orphan drugs and cancer medicines. However, the number of new drugs whose indications were not applied to reimbursement in health insurance was increased. This study aimed to understand the perspectives of experts and various stakeholders on the introduction of a new funding program for cancer treatment and orphan drugs. Methods: We conducted email surveys comprising 19 questions, from September 9 to 26, 2016. We distributed questionnaires to members of the Pharmaceutical Benefit Appraisal Committee and Cancer Assessment Committee. We also conducted a qualitative study through group interviews with stakeholders, including pharmaceutical companies and some patient groups for diseases. Results: A total of 35 survey respondents recommended the introduction of a funding program for orphan drugs, whereas 66% recommended the launch of funding for anticancer drugs. In addition, most pharmaceutical companies and patient groups recommended the introduction of new funding programs targeting patients with cancer and rare diseases. However, some participants asserted that it would be more appropriate to modify the existing reimbursement scheme than launch new funding. Conclusion: This study concluded that introducing new funding needs a social consensus to relieve financial hardships at the patient level.

• 통합자연과학논문집
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• 제4권4호
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• pp.315-322
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• 약학회지
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• 제55권5호
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• pp.426-431
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.