• Title/Summary/Keyword: $\pm$20 rule

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Statistical consideration of assessing bioequivalence in the new KFDA regulation (개정된 생물학적 동등성 시험 기준에 대한 통계적 고찰)

  • 고승곤;양지선;김정일;임남규
    • The Korean Journal of Applied Statistics
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    • v.15 no.2
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    • pp.281-296
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    • 2002
  • On the new medical system separating the prescription and dispensing of the drug, the qualification of pharmacist in substitution of prescribed medicine was restricted, except bioequivalence-certified drugs. Also, Korean Food and Drug Association(KFDA) revised the bioequivalence regulation on August, 2001 Among many changes from old guideline, impressive one is the statistical consideration. Specially, to estimate and analyze bioequivalence measures, AUC and $C_{max}$, the log-transformed model is recommended and the equivalence interval is modified from $\pm$20 rule to [In(0.8),In(1.25)] one. This meaningful act is very hope-for because it is statistically reasonable and is agreed with worldwide bioequivalence guideline, including USA, EU, Japan and Canada. In this paper, we introduce the new regulation of assessing bioequivalence, announced at August, 2001, mainly on statistical view points. Key points for the new regulation are discussed and the minimum sample size based on simulation studies are proposed.

Development of $K-BEtest^{\circledR}$, a Computer Program for the Analysis of Bioequivalence ($K-BEtest^{\circledR}$, 새로운 생물학적 동등성 시험 통계처리 프로그램의 개발)

  • Lee, Young-Joo;Choi, Jung-Ho;Song, Sae-Heum;Seo, Chul-Hwan;Kim, Dong-Sup;Park, In-Sook;Choi, Ki-Hwan;Na, Han-Kwang;Chung, Suk-Jae;Lee, Min-Hwa;Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.28 no.4
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    • pp.223-229
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    • 1998
  • A computer program for personal computers, $K-BEtest^{\circledR}$, was developed to analyze bioequivalence data in accordance with Korean Guidelines for Bioequivalence Test (KGBT). This program is user-friendly, interactive, Hangul-compatible and supports $2{\times}2$ cross-over design as well as $2{\times}2$ Latin square design with various significance levels. This program is able to calculate AUC, $C_{max}$ and $T_{max}$ parameters from the blood drug concentration-time profile of individual subjects and evaluate the parameters statistically for the bioequivalence by ${\pm}20%$ rule, the F-test, the Non-centrality test and 90% confidence intervals. All procedures are supported with graphic interface, interactive menu and outputs in Korean. In this paper, two experimental data sets were analyzed by the program and detailed process was demonstrated. The $K-BEtest^{\circledR}$ program appears to be very effective for analyzing bioequivalence data and can be widely used with convenience and accuracy.

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Cause Analysis in Decrease of Body Stability According to The Induced Astigmatic Blur (유발된 난시성 흐림에 의한 신체 안정성 감소의 원인분석)

  • Kim, Sang-Yeob;Yu, Dong-Sik;Moon, Byeong-Yeon;Cho, Hyun Gug
    • Journal of Korean Ophthalmic Optics Society
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    • v.21 no.3
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    • pp.259-264
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    • 2016
  • Purpose: To establish the cause of decrease in body stability and to analyze the effects on sensory organs maintaining static balance according to the induced astigmatic blur. Methods: Twenty subjects (10 males, 10 females; mean age, $23.40{\pm}2.70years$) were participated in this study. To induce myopic simple astigmatism, the axis directions of cylindrical lenses were placed $180^{\circ}$ on both eyes (with-the-rule), $90^{\circ}$ on both eyes (against-the-rule), and $45^{\circ}$ on both eyes (oblique). Cylindrical lenses of +0.50, +1.00, +1.50, +2.00, +3.00, +4.00, and +5.00 D were used to increase astigmatic blur in each astigmatism types. General stability (ST) and sway power (SP) in frequencies by each sensory organs were analyzed using the TETRAX biofeedback system. Results: ST in the all astigmatism types were raised with increase of astigmatic blur compared to full corrected condition, but a significant difference only showed in the induced oblique astigmatism. According to the results of correlation analysis between ST and SP in the each frequencies with increase of astigmatic blur, the causes of increased ST in the induced oblique astigmatism showed to have a high correlation in order of somatosensory system (high-medium frequency), central nervous system (high frequency), peripheral vestibular system (low-medium frequency), and visual system (low frequency). Conclusions: The visual information by uncorrected oblique astigmatism may disturb the normal functions of all sensory organs maintaining body balance, consequently, the body stability can be reduced. Therefore, optimal correction of astigmatism can play an important role for reducing the instability of body balance.

A Study on Growth Acceleration in Korean as Indirected by the Maximum Growth Age in Body Height (한국인(韓國人) 신장(身長)의 최대발육연령(最大發育年齡)으로 본 발육촉진현상(發育促進現象)의 추이(推移)에 관(關)한 연구(硏究))

  • Shin, Hyung-Gyun;Park, Soon-Young;Park, Yang-Won
    • Journal of Preventive Medicine and Public Health
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    • v.17 no.1
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    • pp.173-192
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    • 1984
  • On the basis of the study intended to research by crosssectional study keeps pace with semilongitudinal study the growthaccelerating phenomena that Maximum Growth age in teenager's body-height. By the random sampling method, the subject of study are 12659 persons(male; 6355, female; 6304) that they are from 7 ages to 17 ages in the whole country including the rural community. The measurement period passed three month days, the statistical data became electronic data processing system with computer. The other side, body-height and MGA of Koreans who had been for during the period from 1925 to 1966 proved transition of the growth-accelerating phenomena by research data reported between 1913 and 1983. The results are as follows; 1. The Growth and Development-Value of Body-height An age bracket the growth and development-value of body-height were, respectively, male is $123.88{\pm}5.05cm$ and female is $123.29{\pm}5.54cm$ for 7 ages group. these indices increased with age. the top-value reach, respectively. $169.08{\pm}5.62cm$ and $157.57{\pm}6.13cm$. The intersecting ages of male and female were the age $8.5{\sim}12.5$, during these periods, female excelled male but after these periods, male excelled female again. In case of body-height, MGA's are 7.0cm for male between 12 and 13 ages, and 7.01cm for female between 8 and 9 ages. As a rule, body-height of male excelled female but intersection phenomena of male and female appeared between 8.5 and 12.5 ages. By reginal groups, it is most prevailing is Seoul, and medium size cities and rural community rome in order. By regional groups, intersection phenomena of male and female are. a region of Seoul; $$8.5{\sim}11.5$$ ages a region of Daejeon; $$7.5{\sim}9.5$$ ages rural community; $$11.5{\sim}14.5$$ ages the whole country's average; $$8.5{\sim}12.5$$ ages By regional groups, the rate of maximum increase in a year are a region of Seoul; male is 7.23cm as 13 ages female is 7.65cm as 9 ages. a region of Daejeon; male is 7.85cm as 11 ages. female is 8.39cm as 9 ages. rural community; male is 7.65cm as 14 ages. female is 6.25cm as 12 ages. the whole country's average; male is 7.0cm as 13 ages. female is 7.01 as 9 ages. 2. Maximum Growth Age (M.G.A.) By reginal groups, maximum Growth Age's are as below in a region of Seoul, MGA's are 12.63 for male and 9.01 for female, which shows that MGA for female appears about 3.5 years earlier than that for male. In a region of Daejeon, MGA's are 9.20 for male and 8.93 for female, which. show that they are all much the same in M.G.A. In rural community, MGA's are 14.00 for male and 11.89 for female, which shows that MGA for female apperars about 2 years earlier than that for male. In the whole average, MGA's are 13.01 for male and 8.97 for femal, which shows that for female appears about 4 years earlier than that for male. For boy, M.G.A. shows fastest-growing in Daejeon, and Seoul and rural commonly come in order. For girl, It shows equal growth in Seoul and Daejeon, rural community comes later. 3. The M.G.A's in body height of male are respectively the age 15.02 in 1913, 14.23 in 1956, 13.86 in 1967, 13.62 in 1975, and 12.82 in 1981, while those of female are the age 12.0 in 1940, 11.52 in 1965, 9.53 in 1975, and 11.16 in 1980; these data show that the MGA of the Koreans has been getting younger. 4. The equation of linear regression of all the MGA's in body height are as follow; Male: Y(M.G.A)=$-0.020{\times}$ (the year)+15.19: female:Y(MGA)=$-0.028{\times}$(the year)+13.2549. 5. The corelation of all the MGA's in body height are as below; male; r=-0.329 female;r=-0.252 6. From the transition of the growth-accelating phenomena in 1980 we can capture the fact that the MGA's has been getting younger by 0.2 year per 10 years. 7. The MGA's in bodyheight are shown in table 4... 8. The future growth-accelating phenomena in body height are expected to show the similar tendency like that of the past, in 1910's but it should by more precisely reviewed after investigating the phenomena of the years directly ahead.

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The Effects of Hot Water Extraction of Wood Meal and the Addition of CaCl2 on Bending Strength and Swelling Ratio of Wood-Cement Board (목질(木質)의 열수추출(熱水抽出) 및 CaCl2 첨가(添加)가 목질(木質)-세멘트 보드의 휨강도(强度) 및 팽윤율(膨潤率)에 미치는 영향(影響))

  • Ahn, Won-Yung;Shin, Dong-So;Choi, Don-Ha
    • Journal of the Korean Wood Science and Technology
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    • v.13 no.3
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    • pp.49-53
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    • 1985
  • The effects of pre-treatments, the hot water extraction of wood meal and the addition of chemical ($CaCl_2$) to wood-cement water system on the properties of wood-cement composite such as modulus of rupture (MOR), modulus of elasticity (MOE), water sorption ratio and swelling ratio of resulting boards were studied in this experiment. The wood meals through 0.83mm(20 mesh) and retained on 0.42mm(35 mesh) screen were prepared from Pinus densiflora S. at Z. and Larix leptolepsis G. For hot water extraction, 500 grams of wood meal for each species were heated to boiling with 1,500ml of distilled water in 2-liter beaker for 6 hours. Every 2 hours, the wood meals were washed with boiling distil1ed water and reheated to boiling again. After 6 hours boiling, the boiled wood particles were collected by pouring this particles on 200 mesh screen. The collected particles then washed twice with hot distilled water and dried for 24 hours in an oven at $109{\pm}20^{\circ}C$. A mixture of 663.4 grams of cement with 331.7 grams of wood meal based on oven-dry weight were dry-mixed in a plastic vessel. The mixture was kneaded with 497.6ml of distilled water in the ratio of 1.5ml of water to a gram of wood meal. To add calcium chloride to the mixture as an accelerator, $CaCl_2$ 4% solution by weight per volume, was added to pine-or larch-cement board in the ratio of 3% to cement weight. To set wood-cement board, this mixture was clamped at 30cm ${\times}$ 30cm, in thickness of 1.5cm for 3 days at room temperature, declamped and then placed at open condition for 17 days. The target density was 1.0. The four specimens sized to 5cm in width and 28cm in length were used for MOR and MOE test for each treatment. After MOR test, the tested specimens were cut to the size of 5cm ${\times}$ 5cm for water sorption and swelling test. The twenty specimens used to measure the water sorption ratio (soaking 24 hours) and ten of these were used for swelling ratio measurement The results obtained were as follows: 1) Larch was not suitable for wood-cement boards because larch-cement board developed no strength, but pine showed 97.9kg/$cm^2$ by hot water extraction. 2) To increase MOR, hot water extraction was more effective than the addition of $CaCl_2$ in pine and larch because the $CaCl_2$ addition was seemed to speed up the ratio of cement hydration without reacting with the wood substances. 3) The water sorption ratio was lowered by the addition of $CaCl_2$ to wood-cement system because the chemical additive accelerated the rate of cement hydration. 4) In pine-cement board, the swelling ratio from 0.37 to 0.42 percent was observed in length and the swelling ratio from 0.88 to 2.0 percent in thickness. As a rule, the swelling ratio of wood-cement board was very low and the swelling ratio in thickness was higher than in length.

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