• Title/Summary/Keyword: Crossover study

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Effects on Mechanical Properties, Joint Range of Motion, and Grip Strength of Forearm Muscles Depending on Wrapping Direction of the Floss Band

  • Ki Bum Jung;Seohui Kim;Yongwoo Lee
    • Physical Therapy Rehabilitation Science
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    • v.13 no.1
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    • pp.95-105
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    • 2024
  • Objective: The purpose was to investigate changes in mechanical properties, range of motion, and grip strength of the forearm muscle in 13 students depending on the wrapping direction of the floss band. Design: A single-blind, crossover study Methods: Subjects were randomly assigned to the wrapping direction of the flossing band and then performed a concentric exercise of the wrist flexors using a Flex-Bar. Intervention A applied the flossing band in a right spiral direction, Intervention B applied the flossing band in a left spiral direction, and Intervention C performed the exercise alone. All subjects used their dominant right hand, and pre- and post-assessments were conducted between interventions. To analyze differences in changes between groups pre- and post-, all results were subjected to one-way ANOVA, followed by Scheffe's test as a post-hoc analysis. The paired samples t-test was used to analyze the difference between pre- and post-change within groups. Results: First, in the mechanical properties of the Flexor carpi ulnaris (FCU) muscle, interventions A and B significantly improved muscle tone and stiffness than intervention C (p<0.05), and intervention A showed a significant decrease in decrement (muscle elasticity) than intervention B (p<0.05). Second, interventions A and B showed significant improvement in grip strength than intervention C (p<0.05). Conclusions: The right spiral direction of the flossing band tended to increase the elasticity of the muscles compared to the left spiral direction. Therefore, in future studies, it is necessary to choose the direction of the flossing band to increase the elasticity of the muscles.

A Genetic Algorithm for Production Scheduling of Biopharmaceutical Contract Manufacturing Products (바이오의약품 위탁생산 일정계획 수립을 위한 유전자 알고리즘)

  • Ji-Hoon Kim;Jeong-Hyun Kim;Jae-Gon Kim
    • The Journal of Bigdata
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    • v.9 no.1
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    • pp.141-152
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    • 2024
  • In the biopharmaceutical contract manufacturing organization (CMO) business, establishing a production schedule that satisfies the due date for various customer orders is crucial for competitiveness. In a CMO process, each order consists of multiple batches that can be allocated to multiple production lines in small batch units for parallel production. This study proposes a meta-heuristic algorithm to establish a scheduling plan that minimizes the total delivery delay of orders in a CMO process with identical parallel machine. Inspired by biological evolution, the proposed algorithm generates random data structures similar to chromosomes to solve specific problems and effectively explores various solutions through operations such as crossover and mutation. Based on real-world data provided by a domestic CMO company, computer experiments were conducted to verify that the proposed algorithm produces superior scheduling plans compared to expert algorithms used by the company and commercial optimization packages, within a reasonable computation time.

Bioequivalence of Kyongbocefaclor Capsule to Ceclor Capsule (Cefaclor 250 mg) (시클러 캡슐(세파클러 250 mg)에 대한 경보세파클러 캡슐의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.1
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    • pp.39-44
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two cefaclor capsules, Ceclor (Lilly Korea Co., Ltd.) and Kyongbocefaclor (Kyongbo Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of cefaclor from the two cefaclor formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $22.96{\pm}1.52$ years in age and $67.03{\pm}7.90$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After one capsule containing 250 mg of cefaclor was orally administered, blood was taken at predetermined time intervals and the concentrations of cefaclor in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Ceclor, were -1.90%, 2.68% and -7.60% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log0.91{\sim}log\;1.06\;and\;log0.92{\sim}log\;1.18\;for\;AUC_t\;and\;C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.

Production of a hypothetical polyene substance by activating a cryptic fungal PKS-NRPS hybrid gene in Monascus purpureus (홍국Monascus purpureus에서 진균 PKS-NRPS 하이브리드 유전자의 발현 유도를 통한 미지 polyene 화합물의 생성)

  • Suh, Jae-Won;Balakrishnan, Bijinu;Lim, Yoon Ji;Lee, Doh Won;Choi, Jeong Ju;Park, Si-Hyung;Kwon, Hyung-Jin
    • Journal of Applied Biological Chemistry
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    • v.61 no.1
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    • pp.83-91
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    • 2018
  • Advances in bacterial and fungal genome mining uncover a plethora of cryptic secondary metabolite biosynthetic gene clusters. Guided by the genome information, targeted transcriptional derepression could be employed to determine the product of a cryptic gene cluster and to explore its biological role. Monascus spp. are food grade filamentous fungi popular in eastern Asia and several genome data belong to them are now available. We achieved transcription activation of a cryptic fungal polyketide synthase-nonribosomal peptide synthase gene Mpfus1 in Monascus purpureus ${\Delta}MpPKS5$ by inserting Aspergillus gpdA promoter at the upstream of Mpfus1 through double crossover gene replacement. The gene cluster with Mpfus1 show a high similarity to those for the biosynthesis of conjugated polyene derivatives with 2-pyrrolidone ring and the mycotoxin fusarin is the representative member of this group. The ${\Delta}MpPKS5$ is incapable of producing azaphilone pigment, providing an excellent background to identify chromogenic and UV-absorbing compounds. Activation of Mpfus1 resulted in a yellow hue on mycelia and its methanol extract exhibit a maximum absorption at 365 nm. HPLC analysis of the organic extracts indicated the presence of a variety of yellow compounds in the extract. This implies that the product of MpFus1 is metabolically or chemically unstable. LC-MS analysis guided us to predict the MpFus1 product and to propose that the Mpfus1-containing gene cluster encode the biosynthesis of a desmethyl analogue of fusarin. This study showcases the genome mining in Monascus and the possibility to unveil new biological activities embedded in it.

Guideline for Bioequivalence Studies of Controlled Release Products (서방성 제제의 생물학적동등성시험을 위한 가이드라인)

  • Seo, Hyun-Ok;Kim, So-Hee;Ahn, Mee-Ryung;Ahn, Choong-Yul;Park, Hye-Jin;Oh, Eun-Kyung;Lee, Eun-Ju;Kim, Bo-Yeon;Kim, Min-Jeong;Woo, Na-Ry;Seo, Hee-Won;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.40 no.1
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    • pp.63-66
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    • 2010
  • The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.

Bioequivalence Test of Gabapentin 800 mg Tablets (가바펜틴 800밀리그람 정제의 생물학적동등성시험)

  • Kim, Se-Mi;Shin, Sae-Byeok;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.4
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    • pp.299-305
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    • 2008
  • Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.

Effects of Taegeuk Acupuncture on the Autonomic Nervous System by Analyzing Heart Rate Variability in 20's Soeumin (태극침법이 정신적 스트레스를 가한 20대 소음인 남성의 심박변이도에 미치는 영향)

  • Kim, Nam Sik;Kim, Jin Youp;Kwak, Sang Gyu;Shin, Im Hee;Nam, Sang Soo;Kim, Yong Suk
    • Journal of Acupuncture Research
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    • v.30 no.3
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    • pp.39-49
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    • 2013
  • Objectives : The purpose of this study is to assess the effect of Taegeuk acupuncture on reducing mental stress by analyzing heart rate variability in Soeumin. Methods : Six Soeumin-diagnosed men participated in this study. They were randomly divided into group A and group B. Each participant went through 4 sessions every week with 1 week of washout period in between each session. HRV was measured three times at every session; at baseline, after administering mentally stressful circumstances and after applying Soeumin Taegeuk acupuncture or Soyangin Taegeuk acupuncture. This study was designed as a crossover clinical trial. Group A participants were treated with two sets of Soeumin Taegeuk and Soyangin Taegeuk acupuncture treatment in respective order (i.e. Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk acupuncture treatment). Group B participants were treated with reverse-ordered acupuncture treatment (i.e. Soyangin Taegeuk - Soeumin Taegeuk - Soyangin Taegeuk - Soeumin Taegeuk acupuncture treatment ). Bayesian analysis was performed by using WinBUGS(Ver. 1.4.3) for comparison between Soeumin Taegeuk acupuncture and Soyangin Taegeuk acupuncture. Results : Overall, Soeumin Taegeuk acupuncture tends to reduce LF/HF ratio, LF, HF, LF(Norm) and increase HF(Norm) more than Soyangin Taegeuk acupuncture, but the difference was not statistically significant. In one participant, however, Soeumin Taegeuk acupuncture reduced LF/HF ratio, LF(Norm) and increased HF(Norm) more than Soyangin Taegeuk acupuncture, and the difference was stastatistically significant. Conclusions : This study suggests that Soeumin Taegeuk acupuncture might be an effective means of stabilizing mental stress-induced imbalance of autonomic nervous system for Soeumin.

The Effect of Solidarity with Non-Cohabiting Children of the Elderly on Successful Aging (노인의 비동거 자녀와의 결속력이 성공적 노화에 미치는 영향)

  • Lee, Su-Jin;Hong, So-Hyoung
    • Journal of Convergence for Information Technology
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    • v.11 no.7
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    • pp.47-56
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    • 2021
  • This study a secondary data analysis study attempted to identify the factors influencing the successful aging of the elderly in Korea. Using the data of the 7th Aging Research Panel in 2018, 4,106 people over 65 years of age who had at least one non-living child and no missing values in the study variables were enrolled. Data were analyzed by frequency analysis, crossover analysis, independent sample t-test, and binary logistic regression analysis. The results of this study revealed that the factors affecting successful aging among elderly included age, the presence or absence of a spouse, education level, housing type, subjective health, exercise, alcohol drinking, and non-face-to-face contact frequency with non-cohabiting children, and the explanatory power of the variables was 24.1%. In order for the elderly to achieve successful aging, centering on child ties, the frequency of non-face-to-face contact, which can comfort the elderly's life and increase the satisfaction of life in a continuous relationship, is more important than having children live close and meet frequently. Based on this study, various strategies are needed for the successful aging of elderly people who are socially isolated due to concerns about COVID-19 infection.

Study on Resources That Influence Drop - Out Teenage Children's Choices on School Reentry: Central Focus on Family Resources (학업중단 청소년 자녀의 학교복귀 선택에 영향을 미치는 자원에 관한 연구: 가족자원 등을 중심으로)

  • Yun, Nana;Park, Jeongyun;Park, Yeonsuk
    • Journal of Family Resource Management and Policy Review
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    • v.26 no.1
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    • pp.27-42
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    • 2022
  • This study was conducted to examine the resources that influence the choice of drop-out students' reentry to school. A total of five years of panel analysis of 2,553 drop-out teenagers from 2013 to 2017 were utilized. In order to verify the resources that affect the choice of school reentry of teenagers with experiences of suspension of studies to formal middle and high school after July 2012, this study analyzed drop-out teenagers' family resources as well as their psychological, mental, and social-relationship resources. A crossover analysis, t-test, and hierarchical logistic regression analysis were conducted. The major outcomes of this study are as follows: First, the socio-demographic variables among the resources that affected the choice of reentry for school of teenager children were the type of family and number of moves to a new house. Second, the psychological and sentimental variable that affected the choice of school reentry was a decreasing level of positive recognition of the situation of suspension of studies combined with depression, impulsiveness, and perceiving society as one that discriminates based on the level of education. Third, significant family resource variables were the type of family form and parents providing economic support, which is a subfactor of parental attachment. Fourth, the presence of a mentor as a helpful social-relationship resource had a significant effect on relational resources. This study is significant in the sense that the positive family resources that affect the choice of school reentry of drop-out teenage students were determined, and the positive directivity of supportive family resources is presented for parents with teenage children experiencing a suspension of studies.

Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017 (CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구)

  • Se-hun Moon;Jung-ho Jo;Seung-kwan Choi;Yun-hee Han;Hyeon-jun Woo;Byeong-hyeon Jeon;Won-bae Ha;Jung-han Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.