위염치료제의 임상시험평가지침 연구

송윤경,진선경,한의식,안미령,정주연,이이다,조일영,김동섭,지은희,박효영,오정미,신원,이선희,김인규,Song, Yun-Kyoung,Jin, Sun-Kyung,Han, Eui-Sik,Ahn, Mee-Ryung,Jung, Ju-Yeon,Lee, Rhee-Da,Cho, Il-Yong,Kim, Dong-Sub,Ji, Eun-Hee,Park, Hyo-Young,Oh, 대한약학회 2011 약학회지 Vol.55 No.4

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석

송윤경,손민지,전아영,김재현,지은희,오정미,김인화,Song, Yun-Kyoung,Sohn, Minji,Jeon, Ah Young,Kim, Jae Hyun,Ji, Eunhee,Oh, Jung Mi,Kim, In-Wha 한국임상약학회 2018 한국임상약학회지 Vol.28 No.2

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

숙지양근탕(熟地養筋湯) 추출물이 흰쥐 좌골신경 손상 후에 기능회복과 염증 매개 인자 발현에 미치는 영향

장건 ( Gun Jang ),송윤경 ( Yun Kyoung Song ),임형호 ( Hyung Ho Lim ) 한방재활의학과학회 2013 한방재활의학과학회지 Vol.23 No.2

Objectives : Peripheral nerve injuries are commonly encountered clinical problems and often result in severe functional deficits. Sukjiyanggeun-Tang(shudiyangjin-tang),in oriental medicine, has been used to treat various musculoskeletal disorders. Methods : In the present study, the effects of aqueous extract of Sukjiyanggeun-Tang(shudiyangjin-tang) on functional recovery, severity of pain, and expressions of neurofilament, cycloxygenease-2(COX-2), inducible nitric oxide synthase(iNOS), and tumor necrosis factor-.(TNF-a) following sciatic crushed nerve injury in rats were investigated. For this study, walking tract analysis, plantar test, western blot analysis for COX-2 iNOS, and TNF-.a and Immunofluorescence test for neurofilament were performed. Results : In the present results, sciatic functional index(SFI) in walking tract analysis was significantly decreased following sciatic crushed nerve injury, and pain severity in plantar test was significantly increased. COX-2, iNOS and TNF-a expressions were increased whereas neurofilament expression was decreased by sciatic crushed nerve injury, In contrast, treatment with Sukjiyanggeun-Tang(shudiyangjin-tang) improved SFI in walking tract analysis and suppressed the pain severity in sciatic crushed nerve injury. Sukjiyanggeun-Tang(shudiyangjin-tang) treatment also suppressed COX-2, iNOS, and TNF-a expressions and enhanced the neurofilament expression in sciatic crushed nerve injury. Conclusions : In the present study, we have shown that Sukjiyanggeun-Tang(shudiyangjin-tang) is the effective therapeutic modality to ameliorate the symptoms of sciatic crushed nerve injury.

의약품 허가 규제 국제 협력에서의 허가참조제도

권진원(Jin-Won Kwon),송윤경(Yun-Kyoung Song),이승미(Seung-Mi Lee),박은혜(Eun-Hye Park),시아차린가린다(Siachalinga Linda),박희영(Hee Young Park),공수진(Su Jin Kong),이인향(Iyn-Hyang Lee) 대한약학회 2021 약학회지 Vol.65 No.2

This study sought to understand the current regulatory collaboration practices of reference country systems in selected countries. The study included eight countries, namely; Nigeria, South Africa, Malaysia, Vietnam, Singapore, Indonesia, Switzerland, Mexico, and two alliances;, namely European Union and ACCESS consortium. The latest data on the reference country systems in the selected countries were collected and analyzed. The reference regulatory authorities include (1) internationally recognized countries (e.g., Stringent Regulatory Authority, SRA), (2) internationally recognized collaborations (e.g. Pharmaceutical Inspection Co-operation Scheme), (3) internationally recognized programs (e.g., WHO Prequalification), and (4) mutual recognition between countries. The SRA is the most frequently mentioned reference in unilateral reference systems, which are not based on mutual recognition. A reference country system could affect regulatory processes in two ways; either by countries requiring market approval from a reference country as a condition for a new application or by reducing the period of review if an applicant submits an assessment report and relevant data reviewed by a reference country. The European Union Mutual Recognition has resulted into efficient work-flow among member states, and similar international alliances are emerging. Of these, the ACCESS consortium is seeking the possibility of a new collaboration not based on geographical region, in contrast to regional collaboration, which seems seclusive to worksharing among nonequivalent member states.

봉독약침과 오공약침이 좌골신경 손상 흰쥐의 기능 회복과 염증 억제에 미치는 영향

이길재 ( Gill Jae Lee ),송윤경 ( Yun Kyoung Song ),임형호 ( Hyung Ho Lim ) 한방재활의학과학회 2013 한방재활의학과학회지 Vol.23 No.2

Objectives : Peripheral nerve injuries are commonly encountered clinical problems and often result in serve functional deficit. Bee venom and scolopendra subspinipes have been traditionally used in oriental medicine to treat several inflammatory diseases and chronic pain conditions. Methods : In the present study, the effects of bee venom pharmacopuncture and scolopendra subspinipes pharmacopuncture on functional recovery, severity of pain, and expressions of neurofilament, cycloxygenease-2(COX-2), and tumor necrosis factor-α(TNF-α) following sciatic crushed nerve injury in rats were investigated. For this study, walking tract analysis, plantar test, western blot for COX-2 and TNF-α, and immunohistochemistry for neurofilament were performed. Results : In the present results, sciatic functional index(SFI) in walking tract analysis was significantly decreased following sciatic crushed nerve injury, and pain severity in plantar test was significantly increased. COX-2 and TNF-α expressions were increased whereas neurofilament expression was decreased by sciatic crushed nerve injury. On the other hand, bee venom pharmacopuncture and scolopendra subspinipes pharmacopuncture improved SFI in walking tract analysis and suppressed the pain severity in sciatic crushed nerve injury. Bee venom pharmacopuncture and scolopendra subspinipes pharmacopuncture suppressed COX-2 and TNF-α expression and enhanced the neurofilament expression in sciatic crushed nerve injury. Conclusions : In the present study, we have shown that treatment with bee venom or scolopendra subspinipes is the effective therapeutic modality to ameliorate the symptoms of sciatic crushed nerve injury. The efficacies of bee venom and scolopendra subspinipes were similar.

의약품 인허가 과정에서 허가참조제도에 대한 전문가 심층 의견

이인향(Iyn-Hyang Lee),권진원(Jin-Won Kwon),송윤경(Yun-Kyoung Song),이승미(Seung-Mi Lee),박은혜(Eun-Hye Park) 한국보건사회약료경영학회 2022 한국보건사회약료경영학회지 Vol.10 No.2

Each country is trying to enhance the efficiency of pharmaceutical licensing procedure by designating their own reference countries that have extensive experience in pharmaceutical regulatory affairs. This study aimed to investigate how Korea can become a regulatory advanced country that other countries can refer to in the pharmaceutical licensing procedure. Focus group or in-depth interviews were conducted with 8 pharmaceutical regulatory experts. The collected data were analyzed using the framework analysis technique. The three themes that emerged from the interviews were; the effectiveness of reference country system, possibilities and obstacles for Korea to become a reference country for other countries, and the prospect for Korea to become a reference country. The positive and negative aspects of reference country system were discussed. The possibility of Korea becoming a reference country for other countries was discussed in two ways; mutual recognition and unilateral recognition. Lastly, it was discussed that it is necessary to enhance the international status of the Ministry of Food and Drug Safety and to change the paradigm of the domestic pharmaceutical market in order for Korea to become a reference country. Based on the above results, short-term and mid-to-long-term strategies were presented for Korea to become a reference country for pharmaceutical licensing procedure as a measure to promote overseas expansion of domestic pharmaceutical companies.