• Title/Summary/Keyword: Drug package

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An R package UnifiedDoseFinding for continuous and ordinal outcomes in Phase I dose-finding trials

  • Pan, Haitao;Mu, Rongji;Hsu, Chia-Wei;Zhou, Shouhao
    • Communications for Statistical Applications and Methods
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    • v.29 no.4
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    • pp.421-439
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    • 2022
  • Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

Analysis of Financial Performance and Its Factors of Community Pharmacies in Korea: After the Introduction of the Separation of Drug Prescription and Dispensing (SPD) Policy (의약분업이후 약국 경영수지 및 관련 요인 분석)

  • Park, Hye-Kyung;Kwon, Chang-Ik;Eom, Tae-Hoon;Kim, Ye-Soon;Rho, Yeun-Sook;Jeong, Gyu-Hyeok;Lee, Eui-Kyoung
    • YAKHAK HOEJI
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    • v.52 no.6
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    • pp.507-513
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    • 2008
  • The purpose of this study is to analyze the factors affecting financial performance of community pharmacies after the implementation of the new drug policy in Korea: separation of drug prescription and dispensing (SPD). The online survey questionnaires were sent to the active pharmacists of the total 20,633 community pharmacies in Korea and 1,147 pharmacists responded to the survey (the response rate was 5.5%). The questionnaire asked simple financial data in order to compare their financial performances before and after the policy. With the SPSS package (version 12.0), two levels of data analysis were used: 1) descriptive statistics to see the financial status of the pharmacies; and 2) multiple regression analysis to find the factors. {or A multiple regression method was used for the data analysis.} The finding illustrated that the average net benefit of the pharmacies was 4,870 thousand won in August 2006, and the major factors affecting the net benefit were the location of pharmacy (geographical proximity to medical institutions), number of prescriptions, drug management services for patients, chain pharmacy membership. The findings of this study suggest that service improvement for patients, revitalization of non-prescription drug sales, professional management will contribute to promote community based pharmacy business.

A Study on strengthening the global competitiveness of Korea's IT industry through exporting the IT package-type service (패키지형 해외진출을 통한 정보통신분야 글로벌 경쟁력 강화 방안에 대한 고찰)

  • Kim, Sun-Bae
    • Journal of the Korea Society of Computer and Information
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    • v.13 no.6
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    • pp.279-286
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    • 2008
  • The IT industry plays the engine role in Korean economy which reaches up to 17% of Korean GDP. However the current global economic depression which stems mainly from the US has caused insufficient demand in IT industry. The decreased demand leads to a drug in the market, to fierce price competitions and increasing fear on the world IT market depression. Considering the facts, there are strong demands for the diversification of the products of exports and the countries Korea exports to. These need differentiated strategies which can be summarized in various IT package-type overseas expansion model including the consideration in strategic items, countries, connecting large and small-medium size companies or businesses and related industries. The importance of IT industry in Korean economy will grow constantly and the IT package-type overseas expansion models will preside the movements.

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Understanding and Use of Nutrition Labeling based on One Serving Size Among Female Consumers in Seoul Area (서울지역 여성소비자의 1회 제공량 기준 영양표시의 이용실태)

  • Shin, Doo-Jee;Jung, Kyoung-Wan;Lee, Gui-Chu;Kwon, Kwang-Il;Kim, Jee-Young;Kim, John-Wook;Moon, Gui-Im;Park, Hye-Kyung;Cho, Yoon-Mi;Kim, Yoo-Kyung
    • Journal of the Korean Society of Food Culture
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    • v.25 no.6
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    • pp.725-733
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    • 2010
  • This study examined the understanding and use of information on nutrition labels based on one serving size among female consumers above the age of 20 in Seoul area. According to the survey, 69.9% of respondents were aware of the current system of nutrition labeling based on one serving size, and 51.8% of the respondents expressed their dissatisfaction with the system because the nutrition labels were difficult to understand or appeared unreliable. The nutrition label literacy of the consumers varied with respect to different packaging units. The respondents were likely to be less accurate in calculating the expected caloric intake when only portions of a multi-serving package were used. Initially 69.0% of respondents reported that they had read the nutrition label before purchasing a product but 91.9% of respondents said that they would check the label after learning how to read the label properly. It is very important to make consumers aware that the labels are very reliable sources of nutrition information. A public education campaign on the use of nutrition labels should focus on developing the consumers' ability and skills in using the label information when choosing foods.

An Analysis on the Factors Affecting Revisit and Defection of Long-term Outpatients in Neighboring Pharmacy of General Hospital (종합병원 장기처방환자의 인근 약국 재방문 및 이탈 요인 분석)

  • Oh, Chang-Kyun;Choi, Byung-Chul;Sohn, Uy-Dong
    • YAKHAK HOEJI
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    • v.49 no.6
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    • pp.449-458
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    • 2005
  • There have been rapid changes in the pharmaceutical environment after the separation of Dispensing and Prescribing practice. In the early stage of this system, outpatients had few options to choose their pharmacies due to various obstacles. Under these circumstances, this study on the defection tendency of long-term care patients was performed through the analysis of outpatients who quit visiting a pharmacy nearby general hospital. PowerBuilder ver 9.0 program was used to extract significant data, and SPSS package was employed for statistic analysis. 3,308 outpatients who visited a pharmacy nearby hospital for a month (in January, 2004) were studied. Patients' sex, age and location of residence, the class of medical insurance, the characteristic type of medication (powder, split form, medication for external use/injection), waiting time, disease (department) were considered as variable factors. It turned out that the patient revisit ratio was 80.8$\%$ and the patient defection ratio was 32.4$\%$. As was expected, those factors mentioned above influenced on the revisit and defection ratio considerably. In terms of patient factors, it proved that there was no relationship among sex, location of residence, the class of medical insurance and revisit (defection) ratio. Only age factor influenced the ratio; the older, the higher revisit ratio and the less defection ratio. In respect of dispensing factors, there were obvious relationships among the factors and the ratio: bill (money they had to pay individually), waiting time, number of medications, splitting of tablets, unit price of drug and revisit (defection) ratio showed significant relationship. The result of this study revealed an aspect of outpatients' behavior and it could be used as a reference for better patient service and customer relationship management.

Identification of novel potential drugs and miRNAs biomarkers in lung cancer based on gene co-expression network analysis

  • Sara Hajipour;Sayed Mostafa Hosseini;Shiva Irani;Mahmood Tavallaie
    • Genomics & Informatics
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    • v.21 no.3
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    • pp.38.1-38.8
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    • 2023
  • Non-small cell lung cancer (NSCLC) is an important cause of cancer-associated deaths worldwide. Therefore, the exact molecular mechanisms of NSCLC are unidentified. The present investigation aims to identify the miRNAs with predictive value in NSCLC. The two datasets were downloaded from the Gene Expression Omnibus (GEO) database. Differentially expressed miRNAs (DEmiRNA) and mRNAs (DEmRNA) were selected from the normalized data. Next, miRNA-mRNA interactions were determined. Then, co-expression network analysis was completed using the WGCNA package in R software. The co-expression network between DEmiRNAs and DEmRNAs was calculated to prioritize the miRNAs. Next, the enrichment analysis was performed for DEmiRNA and DEmRNA. Finally, the drug-gene interaction network was constructed by importing the gene list to dgidb database. A total of 3,033 differentially expressed genes and 58 DEmiRNA were recognized from two datasets. The co-expression network analysis was utilized to build a gene co- expression network. Next, four modules were selected based on the Zsummary score. In the next step, a bipartite miRNA-gene network was constructed and hub miRNAs (let-7a-2-3p, let-7d-5p, let-7b-5p, let-7a-5p, and let-7b-3p) were selected. Finally, a drug-gene network was constructed while SUNITINIB, MEDROXYPROGESTERONE ACETATE, DOFETILIDE, HALOPERIDOL, and CALCITRIOL drugs were recognized as a beneficial drug in NSCLC. The hub miRNAs and repurposed drugs may act a vital role in NSCLC progression and treatment, respectively; however, these results must validate in further clinical and experimental assessments.

A Study on Residual Amounts of Vinyl Chloride/Vinylidene Chloride in Poly(vinyl chloride)/Poly(vinylidene chloride) Food Packaging using Headspace GC/MS (헤드스페이스 GC/MS를 이용한 폴리염화비닐/폴리염화비닐리덴 식품 포장 중 염화비닐/염화비닐리덴 잔류량 연구)

  • Sung, Jun-Hyun;Kwak, In-Shin;Park, Sung-Kwan;Kim, Hyung-Il;Lim, Ho-Soo;Lee, Ju-Young;Byun, Mi-Yun;Kim, So-Hee
    • Korean Journal of Food Science and Technology
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    • v.43 no.1
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    • pp.6-11
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    • 2011
  • Vinyl chloride (VC) and vinylidene chloride (VDC), which may be present in poly(vinyl chloride) (PVC) and poly(vinylidene chloride) (PVDC) food packaging, were analyzed by using a headspace-gas chromatograph (GC)/mass spectrometer (MS) equipped with a PLOT Q column. 1-Chloropropane (1-CP) was used as an internal standard. The determinations of VC and VDC were carried out by monitoring the characteristic ions for each compound: m/z=61, 62, 64 and m/z=61, 96, 98, respectively. The method validated in this study can be suitable for the compliance test of EU regulation. Among 103 food packaging samples, VC and VDC were not detected, except in one PVDC food package. However, the detected level of VDC in the sample was below the EU regulatory specific limitation.

A Study on the Development Strategy of Continuing Education Package for the Community Health Practitioners (보건진료원을 위한 보수교육자료의 개발방향)

  • Kang Young-Sil
    • Journal of Korean Public Health Nursing
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    • v.6 no.1
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    • pp.5-14
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    • 1992
  • The role of Community Health Practitioner(CHP) should be continuously adapted to the social changes and the needs for health care services. That is the reason CHP needs to be retrained through the continuing education program. This paper showed CHP's roles to be reinforced by analyzing his present . task performance and ability in seven task areas as well as the changes of the social environment. In addition, this paper presented retraining areas needed for the reinforcement of the CHP's role in the future, and the development strategy of related continuing education package. The major results are as follows: 1. CHP's main practice area is health care services and management & guidance, whereas the development of health information system is neglected. 2. As a result, CHP plays a role mainly as a health care supplier, a consultant and a health instructor. Therefore CHP's roles to be reinforced are management of the community health system, act as a spokesman and a team member, promotion, assessment, collection & maintenance of information, coordination and research. 3. The areas to be reinforced in CHP's continuing education are (]) aged people's health, (2)?drinking & smoking, (3)?young people's health(including drug and sexualissues), (4) rehabilitation, (5)?administration and management for community health, (6)?partnership & membership, (7) local residents' participation and community development, (8) collection & treatment of health information and (9) environmental issues for community health. 4. The priority in developing continuing education package should be given to the area, which is encountered often in rural area but important, and has a good opportunity to be resolved. The health management of aged people was selected as a top priority by members of the Community Nursing Academic Society. 5. It is recommended that the instruction materials be accommodated to the small scale workshop or seminar in order that CHPs can participate actively in the continuing education program.

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A Study on Migration of Formaldehyde and Phenol from Melamine-wares (멜라민 수지 조리기구 중 formaldehyde 및 phenol의 이행에 관한 연구)

  • Oh, Jae-Myoung;An, Mi-Kyung;Kim, Jin-Chul;Shin, Dong-Woo;Park, Chang-Won;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.29 no.1
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    • pp.21-25
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    • 2014
  • Formaldehyde and phenol used in the production of melamine-wares may be intended to come into foodstuffs. So this study investigated the migration of formaldehyde and phenol from 222 articles Articles were cups(14), bowls(75), plates(85), spoons(10), chopsticks(4), food trays(8), rice paddles(4), spatulas(9) and scoops(12). The food stimulants were 4% acetic acid, 20% ethanol, distilled water and n-heptane. Korea regulation (Standards and specifications for food utensils, containers and package) specifies migration limits for formaldehyde and phenol in food stimulants. Formaldehyde and phenol are restricted by 4 mg/L, 5 mg/L respectively. In all cases the migration of formaldehyde and phenol were below the limit set in Korea regulation. The level of formaldehyde and phenol migrated to food simulants were in the range of N.D~2.949 mg/L, N.D~0.078 mg/L respectively. These migration results of formaldehyde and phenol will provide a scientific basis for the safety management of melamine-wares.

IDENTIFICATION OF FALSIFIED DRUGS USING NEAR-INFRARED SPECTROSCOPY

  • Scafi, Sergio H.F.;Pasquini, Celio
    • Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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    • 2001.06a
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    • pp.3112-3112
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    • 2001
  • Near-Infrared Spectroscopy (NIRS) was investigated aiming at the identification of falsified drugs. The identification is based on comparison of the NIR spectrum of a sample with a typical spectra of an authentic drug using multivariate modelling and classification algorithms (PCA/SIMCA). Two spectrophotometers (Brimrose - Luminar 2000 and 2030), based on acoustic-optical filter (AOTF) technology, sharing the same controlling computer, software (Brimrose - Snap 2.03) and the data acquisition electronics, were employed. The Luminar 2000 scans the range 850 1800 nm and was employed for transmitance/absorbance measurements of liquids with a transflectance optical bundle probe with total optical path of 5 mm and a circular area of 0.5 $\textrm{cm}^2$. Model 2030 scans the rage 1100 2400 nm and was employed for reflectance measurement of solids drugs. 300 spectra, acquired in about 20 s, were averaged for each sample. Chemometric treatment of the spectral data, modelling and classification were performed by using the Unscrambler 7.5 software (CAMO Norway). This package provides the Principal Component Analysis (PCA) and SIMCA algorithms, used for modelling and classification, respectively. Initially, NIRS was evaluated for spectrum acquisition of various drugs, selected in order to accomplish the diversity of physico-chemical characteristics found among commercial products. Parameters which could affect the spectra of a given drug (especially if presented as solid tablets) were investigated and the results showed that the first derivative can minimize spectral changes associated with tablet geometry, physical differences in their faces and position in relation to the probe beam. The effect of ambient humidity and temperature were also investigated. The first factor needs to be controlled for model construction because the ambient humidity can cause spectral alterations that should cause the wrong classification of a real drug if the factor is not considered by the model.

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