• Journal of Digestive Cancer Research
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• 제1권2호
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• pp.73-77
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• 2013

Gastrointestinal (GI) cancers are top priorities for cancer control in Korea. In terms of epidemiological, population-health and economic burden, GI cancers such as stomach, liver and colorectal cancers have been top four cancers in the nation during the past decade and this trend is likely to continue in the near future. In order to reduce the great burden of GI cancer in Korea, the nation might need the following strategies: (1) to put more focus on primary prevention on infection/diet and related research; (2) to improve screening rates for colorectal and stomach cancers, and conduct more cost-effectiveness analysis of these screening programs, e.g., Fecal Occult Blood Test vs. colonoscopy; (3) to establish a more consistent and integrative cost-effectiveness analysis system for new cancer treatments and anticancer drugs; and (4) to place more emphasis on hospice and other palliative care of GI cancer, as well as on the etiology, staging and treatment of pancreas cancer with its poor survival rate.

• Childhood Kidney Diseases
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• 제27권2호
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• pp.55-63
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• 2023

In 2021, a new chapter on the general management of glomerulonephritis (GN) was added to the Kidney Disease: Improving Global Outcomes (KDIGO). It emphasizes the importance of early general management of GN for improving long-term kidney outcomes and prognosis. The chapter introduces the management of glomerular diseases in 18 subchapters. Here, kidney biopsy for the diagnosis and evaluation of kidney function and the management of complications, such as hypertension, infection, and thrombosis, are presented. Moreover, the adverse effects of glucocorticoids and immunosuppressive therapy, which are commonly used drugs for glomerular disease, are mentioned, and a guideline for drug selection is presented. Each subtheme focused on items reflecting the interpretation of the "practice points" of the expert working group are introduced. In this review of the general treatment for GN in the KDIGO guidelines, excluding pregnancy and reproductive health, we focused on and compared various references pertaining to pediatric GN management.

• 대한수의학회지
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• 제63권3호
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• pp.22.1-22.4
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• 2023

The increasing resistance of head lice Pediculus humanus capitis to many drugs has highlighted the need for new alternatives to control head lice in adults. The effect of two types of extracts (aqueous and alcoholic) of Citrullus colocynthis fruit on adult lice was tested in vitro. The results showed that the alcoholic extract with a concentration of 20% showed similar efficacy in killing adult lice to that of Natroba 9% w/w, with values ranging between 87% to 98% within 18 minutes, followed by a 20% aqueous extract with a 44% to 79% death rate. A 10% concentration of both types of extracts had moderate lethality for lice, while a 5% concentration did not show strong lethality for adult lice. These results revealed significant differences between the control group and those treated with alcoholic and aqueous extract concentrations of C. colocynthis fruits at the probability level p ≤ 0.05.

• Biomolecules & Therapeutics
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• 제32권1호
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• pp.13-24
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• 2024

Cytokines influence the overall cancer immune cycle by triggering tumor antigen expression, antigen presenting, immune cell priming and activation, effector immune cell recruitment and infiltration to cancer, and cancer killing in the tumor microenvironment (TME). Therefore, cytokines have been considered potential anti-cancer immunotherapy, and cytokine-based anti-cancer therapies continue to be an active area of research and development in the field of cancer immunotherapy, with ongoing clinical trials exploring new strategies to improve efficacy and safety. In this review, we examine past and present clinical developments for major anticancer cytokines, including interleukins (IL-2, IL-15, IL-12, IL-21), interferons, TGF-beta, and GM-CSF. We identify the current status and changes in the technology platform being applied to cytokine-based immune anti-cancer therapeutics. Through this, we discuss the opportunities and challenges of cytokine-based immune anti-cancer treatments in the current immunotherapy market and suggest development directions to enhance the clinical use of cytokines as immuno-anticancer drugs in the future.

• IMMUNE NETWORK
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• 제21권6호
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• pp.40.1-40.20
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• 2021

Mycobacteroides abscessus (previously Mycobacterium abscessus; Mabc), one of rapidly growing nontuberculous mycobacteria (NTM), is an important pathogen of NTM pulmonary diseases (NTM-PDs) in both immunocompetent and immunocompromised individuals. Mabc infection is chronic and often challenging to treat due to drug resistance, motivating the development of new therapeutics. Despite this, there is a lack of understanding of the relationship between Mabc and the immune system. This review highlights recent progress in the molecular architecture of Mabc and host interactions. We discuss several microbial components that take advantage of host immune defenses, host defense pathways that can overcome Mabc pathogenesis, and how host-pathogen interactions determine the outcomes of Mabc infection. Understanding the molecular mechanisms underlying host-pathogen interactions during Mabc infection will enable the identification of biomarkers and/or drugs to control immune pathogenesis and protect against NTM infection.

• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 응용통계연구
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• 제15권2호
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• pp.281-296
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• 2002

2000년도 의약분업으로 심화된 대체 조제에 대한 논란은 의사의 사전 동의 없이 대체조제 가능 품목을 식품의약품안전청장이 생물학적 동등성이 있다고 인정한 품목으로 제한함으로서 마무리되었다. 이에 발맞추어 식품의약품안전청(KFDA)은 후발 의약품에 대한 생물학적 동등성 시험 기준을 개정하였으며, 이 중에서 눈에 띄는 부분은 통계적인 고려 사항이다. 특히, 대조약과 시험약간의 동등성 판단을 위한 비교항목의 로그 변환을 명시한 것은 통계적 검증의 타당성 확보뿐만 아니라 국제적인 의약품 허가 추세에 부응한 바람직한 조치라 할 수 있다. 본 논문에서는 개정된 생물학적 동등성 시험 기준에서 고려 된 AUC와 Gmax의 로그 변환(log transformation)을 중심으로 그 배경과 통계적 의미를 고찰해 보고, 기존의 생물학적 동등성 판단 기준과 비교 검토해 보고자 한다. 또한 모의실험을 통해 개정된 기준의 통계적 타당성을 확인하고, 올바른 생물학적 동등성 판단을 위한 최소 표본수를 제안해 보기로 한다.

• 기술혁신연구
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• 제20권1호
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• pp.141-167
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• 2012

기술 혁신과 더불어 해당 기술을 기반으로 한 제품의 성공적 시장진입은 지속적 혁신의 기반이 된다. 본 연구는 기술집약적인 제약 산업에서 신약의 성공적 출시에 영향을 미치는 요인을 살펴보고 있다. 특히 선발자의 우위와 후발자의 우위에 대한 상반된 이론하에서 언제 선발자의 우위가 후발자에 의해 완화되어 후발제품이 시장 선도제품을 추월할 수 있는지를 중점적으로 살펴보았다. 구체적으로 선발제품과 후발제품의 시장 진입 시간차가 커서 후발자가 선발자의 정보를 충분히 흡수할 수 있을 때, 제품의 향상과 차별화가 가능하여 후발제품이 선발제품을 추월할 확률은 높아진다. 또한 후발자의 마케팅 역량이 크면 선발제품의 고객기반을 보다 효과적으로 극복할 수 있어 후발제품이 선발제품을 추월할 확률이 높아지는 것으로 나타났다. 이러한 결과는 진입이 늦어진 후발자의 입장에서 뒤처진 시간을 활용하여 오히려 성공 확률을 높일 수 있는 후발자의 우위를 재조명하며, 우수한 기술을 바탕으로 개발된 신제품이라 할지라도 높은 마케팅 역량이 뒷받침되어야 선발자의 우위를 극복하고 시장 추격의 확률을 높일 수 있다는 실질적인 시사점을 제공한다.

• 약학회지
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• 제53권6호
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• pp.303-313
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• 2009

Traditionally, Cham dang-gui (Angelica gigas Nakai) is one of the most popular herbal medicines in Asian countries including Korea. A. gigas has been used as a functional food product for treatment anemia, women's health care, a sedative, an anodyne or a tonic agent. Decursin and decursinol angelate isolated from the roots of A. gigas are pyranocoumarin compounds. Recently, as the global herbal medication market is increasing, investigations about pharmacological effects of decursin and decursinol angelate are rapidly increasing. We summarized previous studies about pharmacological effects of decursin and decursinol angelate, and reviewed relation with pharmacological effects of decursin and decursinol angelate on human disorder, focused on the approach for new drug development. Pharmacological effects of decursin and decursinol angelate were classified as anti-tumor activity, anti-bacterial activity, improvements of the circulating system, inhibition of cytochrome P-450 activity, anti-inflammation activity, anti-oxidant activity and cognitive-enhancing activites. The activity of A. gigas with improvement of the circulating system may have wide therapeutic potential for circulatory diseases, including diabetes, hyperlipidemia and atherosclerosis. Also, anti-inflammation activity A. gigas may be beneficial for the treatment and prevention of asthma, atopic dermatitis and rheumatism arthritis. This relation could potentially lead to the development of herbal new drugs. In order to development a new drug containing decursin and decursinol angelate, it is also necessary to consider the safety profile, and the information in this review would contribute to development a new drug from herbal medicine.

• 대한한의학회지
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• 제31권3호
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• pp.1-7
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• 2010

Objectives: To introduce to TKM scientific dose conversion methods of human to animal or animal to human for new drug investigations. Methods: We searched guidelines of the FDA and KFDA, and compared them with references for drug-dose conversion from various databases such as PubMed and Google. Then, we analyzed the potential issues and problems related to dose conversion in safety documentation of new herbal drugs based on our experiences during Investigational New Drug (IND) applications of TKM. Results: Dose conversion from human to animal or animal to human must be appropriately translated during new drug development. From time to time, investigators have some difficulty in determining the appropriate dose, because of misunderstandings of dose conversion, especially when they estimate starting dose in clinical or animal studies to investigate efficacy, toxicology and mechanisms. Therefore, education of appropriate dose calculation is crucial for investigators. The animal dose should not be extrapolated to humans by a simple conversion method based only on body weight, because many studies suggest the normalization method is based mainly on body surface area (BSA). In general, the body surface area seems to have good correlation among species with several parameters including oxygen utilization, caloric expenditure, basal metabolism, blood volume and circulating plasma protein. Likewise, a safety factor should be taken into consideration when deciding high dose in animal toxicology study. Conclusion: Herein, we explain the significance of dose conversion based on body surface area and starting dose estimation for clinical trials with safety factor.