• 제목/요약/키워드: $\pm$20 rule

검색결과 25건 처리시간 0.018초

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

  • 고승곤;양지선;김정일;임남규
    • 응용통계연구
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    • 제15권2호
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    • pp.281-296
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    • 2002
  • 2000년도 의약분업으로 심화된 대체 조제에 대한 논란은 의사의 사전 동의 없이 대체조제 가능 품목을 식품의약품안전청장이 생물학적 동등성이 있다고 인정한 품목으로 제한함으로서 마무리되었다. 이에 발맞추어 식품의약품안전청(KFDA)은 후발 의약품에 대한 생물학적 동등성 시험 기준을 개정하였으며, 이 중에서 눈에 띄는 부분은 통계적인 고려 사항이다. 특히, 대조약과 시험약간의 동등성 판단을 위한 비교항목의 로그 변환을 명시한 것은 통계적 검증의 타당성 확보뿐만 아니라 국제적인 의약품 허가 추세에 부응한 바람직한 조치라 할 수 있다. 본 논문에서는 개정된 생물학적 동등성 시험 기준에서 고려 된 AUC와 Gmax의 로그 변환(log transformation)을 중심으로 그 배경과 통계적 의미를 고찰해 보고, 기존의 생물학적 동등성 판단 기준과 비교 검토해 보고자 한다. 또한 모의실험을 통해 개정된 기준의 통계적 타당성을 확인하고, 올바른 생물학적 동등성 판단을 위한 최소 표본수를 제안해 보기로 한다.

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

  • 이영주;최정호;송세흠;서철환;김동섭;박인숙;최기환;나한광;정석재;이민화;심창구
    • Journal of Pharmaceutical Investigation
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    • 제28권4호
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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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유발된 난시성 흐림에 의한 신체 안정성 감소의 원인분석 (Cause Analysis in Decrease of Body Stability According to The Induced Astigmatic Blur)

  • 김상엽;유동식;문병연;조현국
    • 한국안광학회지
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    • 제21권3호
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    • pp.259-264
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    • 2016
  • 목적: 유발된 난시성 흐림이 정적균형을 유지시키는 다른 감각기관들에 미치는 영향을 분석하여 신체 안정성을 감소시키는 원인을 규명하고자 하였다. 방법: 평균 나이 $23.40{\pm}2.70$세의 20명을 대상으로 하였다. 근시성 단성난시를 유발하기 위해 (+)원주렌즈의 축을 양안에 $180^{\circ}$(직난시), $90^{\circ}$(도난시), 그리고 $45^{\circ}$(사난시) 방향으로 위치시켰으며, 각각의 방향에 +0.50 D, +1.00 D, +1.50 D, +2.00 D, +3.00 D, +4.00 D, 그리고 +5.00 D의 원주렌즈를 이용해 각 난시유형별로 난시성 흐림을 증가시켰다. TETRAX biofeedback system을 이용하여 각 조건에 따른 안정성 지수(ST)와 각 감각기관에 해당하는 4가지 주파수의 흔들림 강도(SP)를 측정하였다. 결과: 난시성 흐림이 커질수록 유발된 모든 난시유형에서 ST는 완전교정상태와 비교해 증가하였지만, 유발된 사난시에서만 유의한 차이를 보였다. 난시성 흐림이 증가함에 따른 ST의 증가와 각 주파수별 SP간의 상관분석결과, 유발된 사난시에서 신체 안정성을 저하시키는 원인으로 체성계(중 고주파수), 중추신경계(고주파수), 말초전정계(중 저주파수), 그리고 시각계(저주파수)의 영향 순으로 높은 상관성을 보였다. 결론: 미교정된 사난시로 인한 시각정보는 신체균형을 유지시키는 모든 감각기관의 정상적인 기능을 방해하여 신체 안정성을 감소시킬 수 있다. 따라서 최적의 난시교정은 신체균형의 불안정성을 제거시키는 중요한 요인이 될 수 있다.

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) (A Study on Growth Acceleration in Korean as Indirected by the Maximum Growth Age in Body Height)

  • 신형균;박순영;박양원
    • Journal of Preventive Medicine and Public Health
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    • 제17권1호
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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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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) (The Effects of Hot Water Extraction of Wood Meal and the Addition of CaCl2 on Bending Strength and Swelling Ratio of Wood-Cement Board)

  • 안원영;신동소;최돈하
    • Journal of the Korean Wood Science and Technology
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    • 제13권3호
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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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