인과립구 콜로니 자극인자 제제인 HM10411 와 필그라스팀의 정맥 , 근육 및 피하 주사시 흰쥐와 마우스에서의 약물 동태

김인화(In Wha Kim),이상훈(Sang Hoon Lee),김영민(Young Min Kim),정성엽(Sung Youb Jung),권세창(Se Chang Kwon),이관순(Kwan Soon Lee),정석재(Suk Jae Chung),심창구(Chang Koo Shim) 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.2

N/A The pharmacokinetics of recombinant human granulocyte colony stimulating factor (rhG-CSF) following intravenous (i.v.), intramuscular (i.m.) and subcutaneous (s.c.) administration of HM10411-lyo and HM10411-liq (lyophilized and liquid formulations of rhG-CSF, recently under development by Hanmi Pharmaceutical Company) were studied in rats, and compared with that of Filgrastim (conventional formulation of rhG-CSF on market). The plasma concentration of rhG-CSF was quantified using a specific ELISA. The pharmacokinetic parameters of rhG-CSF, after i.v., i.m. and s.c. administration of Filgrastim, HM10411-1yo and HM 10411-liq to rats at a rhG-CSF dose of 10 ㎍/kg, were almost identical among the three formulations. No dose-dependency was observed in the pharmacokinetic parameters of rhG-CSF following i.v. administration in the dose range of 5∼ 100 ㎍/kg. rhG-CSF, after i.v. administration of the three preparations at a dose of 10 ㎍/kg to rats, was detected at low levels in all of the body tissues with highest tissue/plasma ratio of 0.46∼0.51 for the kidney at 30 min after the administration. The pharmacokinetics of rhG-CSF, after i.v. administration to mice at a dose of 10 ㎍/kg, were comparable among the three formulations. In conclusion, HM1041l-lyo and HM10411-liq exhibited similar pharmacokinetics for rhG-CSF with Filgrastim regandless of animal species. Considering the fact that HM10411 series, contrary to Filgrastim, are proteins lacking a methionine residue, the methionine moiety in rhG-CSF molecule does not appear to influence the pharmacokinetics of the protein significantly.

록소닌 정 ( 록소프로펜 나타륨 무수물 60mg ) 에 대한 록시펜 정의 생물학적 동등성

김인화(In Wha Kim),한태규(Tae Gyu Han),김경식(Kyung Sik Kim),정석재(Suk Jae Chung),이민화(Min Hwa Lee),심창구(Chang Koo Shim) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.3

A bioequivalence study of the Loxipen tablets (Dae Wha Pharmaceutical Co., Korea) to the Loxonin tablets (Dong Hwa Pharmaceutical Co., Korea), formulations of sodium loxoprofen anhydrous 60㎎, was conducted. Sixteen healthy Korean male subjects received each formulation at the dose of 60㎎ as sodium loxoprofen anhydrous in a 2×2 crossover study. There was a 2-week washout period between the dose. Plasma concentrations of loxoprofen were monitored by an HPLC method for over a period of 6 h after each administration. AUC (area under the plasma concentration-time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. C_(max) (maximum plasma drug concentration) and T_(max) (time to reach C_(max)) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, C_(max) and T_(max) between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 5.88, 7.81 and 6.09% for AUC, C_(max) and T_(max), respectively). Minimum detectable differences (%) at α=0.1 and 1-β=0.8 were all less than 20% difference in these parameters between the formulations were all over 0.8 (i.e., 15.81, 13.13 and 19.85 for AUC, C_(max) and T_(max), respectively). The 90% confidence intervals for these parameters were also within ±20% (i.e., -16.52∼4.77, -16.65∼1.02 and -19.45∼7.28% for AUC, C_(max) and T_(max), respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the 2 formulations of loxoprofen are bioequivalent and, thus, may be prescribed interchangeably.

이호원,하정욱 화갑기념호 : 사과피분말 첨가식이가 성장기 흰쥐의 체내 지질대사에 미치는 영향

김인화 ( In Wha Kim ),신동순 ( Dong Soon Shin ) 경남대학교 기초과학연구소 2002 기초과학지 Vol.16 No.-

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.

안감소재에 따른 여름철 원피스드레스의 주관적 착용감 평가

권수애 ( Soo Ae Kweon ),최종명 ( Jong Myoung Choi ),김인화 ( In Wha Kim ) 한국감성과학회 2003 추계학술대회 Vol.2003 No.-

여름철 더운환경과 냉방환경에서 안감소재별 6종의 원피스 드레스의 주관적 착용감을 평가한 결과, 안감소재에 따라 원피스 드레스의 주관적 착용감은 유의한 차이를 나타내어 고온환경에서는 레이온 안감이, 냉방환경에서는 아세테이트 안감의 착용감이 좋은 것으로 나타났다. 여름철 환경에서는 의복기후보다 주관적 착용감이 쾌적감에 더 큰 영향을 미치는 요인을 나타났다.

식품의약품안전청의 의약품안전사용정보방 웹사이트 구축을 위한 컨텐츠 개발

지은희(Eunhee Ji),박효영(Hyo Yung Park),노혜진(Hyejin Noh),이동은(Dong Eun Lee),한나영(Nayoung Han),정소현(Sohyun Jeong),김인화(In-Wha Kim),신완균(Wan Gyoon Shin),오정미(Jung Mi Oh) 대한약학회 2012 약학회지 Vol.56 No.3

The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman’s terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA’s ongoing initiative to address and promote the safe use of medications for the public.

사과피분말 첨가식이가 성장기 흰쥐의 체내 지질대사에 미치는 영향

김인화,신동순 慶南大學校 附設 基礎科學硏究所 2002 硏究論文集 Vol.16 No.-

본 연구는 성장기 흰쥐에게 사과피 분말로 공급된 식이섬유소의 수준이 체내 지질대사에 미치는 영향을 살펴봄으로써 식이섬유소 섭취의 적정수준을 제시하고자 시도되었다. 평균 체중 133.6g의 Sprague-Dawley종 흰쥐를 대조군(0%)과 2.5%, 5% 및 10% 사과피 공급군으로 분류하여 4주간 사육하였다. 대조군과 비교할 때, 사과피 공급군들의 식이 섭취량은 많고 체중 증가량은 낮아서, 사과피 공급군의 식이효율은 전반적으로 대조군보다 낮았으며 특히 5% 공급군의 식이효율이 가장 낮았다. 정소상체 지방조직의 무게는 모든 사과피 공급군들이 대조군보다 낮아서, 최소한 2.5% 사과피 공급군에서도 지방축적에 대한 억제 효과가 있음을 보여주었다. LDL-콜레스테롤(c)농도는 5% 사과피 공급군에서 유의적으로 낮았으며, HDL-c농도는 5%, 10% 공급군에서 대조군보다 높아서 동맥경화지수는 사과피의 공급수준이 높아질수록 낮았다. 결론적으로 5% 미만의 사과피 공급 수준으로 장기 성장에 영향을 주지않고 지방축적 억제효과를 유도할 수 있었으며, 5% 이상의 사과피 공급 수준으로 혈액 지질성분의 농도를 변화시킬 수 있었다. This study was conducted to confirm the optimal level of dietary fiber for lipid metabolism in growing animals fed with the diet mixed with the apple peel powder as fiber sources. The Sprague-Dawley rats, weighing 133.6g in initial average, were used for 4 weeks. The rats were divided into four groups of the control group(0%), 2.5%, 5% and 10% apple peel group. The results were as follows : The rats of all three apple peel groups consumed more food than the control, but their weights were less. The FER of 5% apple peel group was significantly lower than the control. The weights of epididymal fat pad in all apple peel groups were much less than the control. The serum concentration of LDL -cholesterol (c) in 5% apple peel group were significantly lower and of HDL-c in 5% and 10% group were higher compared to the control. Therefore the more the intake of apple peel powder was, the lower the atherogenic index(AI) was. In conclusion it was showed that the diet of more than 5% apple peel fiber improved the serum lipid profile but that of less than 5% apple peel fiber could be able to prevent the body fat accumulation without any effect on the FER and organ growth in young animals.

고인습성 약물인 피리도스티그민의 마이크로캅셀화에 의한 분체 특성의 개선

김대석,김인화,정석재,심창구 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.1

The purpose of this study is to microencapsulate a highly hygroscopic drug, pyridostigmine bromide (PB), with a waterproof wall material, in order to increase the flowability of the drug particles. Polyvinylacetaldiethylaminoacetate (AEA), Eugragit E and Eugragit RS were examined as the wall materials. Microcapsules containing PB were prepared by the evaporation technique in an acetone/liquid paraffin system using aluminum tristearate as a core material, and evaluated for drug encapsulation efficiency, surface morphology, particle size and drug dissolution. The encapsulation of PB in the wall material was almost complete. Among the wall materials examined, AEA exhibited the most excellency in shape, surface texture, flowability, size distribution of microcapsules. Above results suggest that AEA would be a potential wall material for microcapsulation of highly hygroscopic drugs, such as PB. Through microencapsulation with AEA, inconvenience of handling of PB powders encountered in the process of weighing and packing the powders to tableting die or capsule body could be greatly improved.

겔제제로부터 케토프로펜의 방출특성 시험법

김호정,윤미옥,이수정,최현철,김지영,김인화,심창구,강신정 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.2

A method that describes the determination of the in vitro release of ketoprofen from gels was suggested. The experimental system of the method consists of a Franz diffusion cell, which contains a pH 7.4 phosphate buffer as a receptor medium, and a 70 μm mesh woven nylon membrane as a diffusion barrier. Under the given condition of the system, the diffusion of ketoprofen across the membrane was rapid enough that the apparent release profile of ketoprofen obtained from the present method could represent the release of the drug from gel preparations. The release of ketoprofen in the present method was reproducible, and the rate increased in proportion to the concentration of ketoprofen in the gel. These suggest that the present method is applicable to the quality evaluation of gel preparations containing ketoprofen.