결락이 있는 3×3 교차설계법에서의 생물학적 동등성시험

임남규,김정일 대전대학교 기초과학연구소 2000 自然科學 Vol.11 No.2

최근 동일한 유효 성분을 가지면서 용량 혹은 형식만이 다른 제제의 개발이 증가되고 이에 따라 두 제제 이상에 대한 생물학적 동등성 시험의 필요성이 제기되고 있다. 중앙약심은 한 회사에서 개발된 제품으로서 동일한 유효성분을 함유하고 용량만이 다른 두 시험제제에 대하여 동시에 시험을 행할 경우에 3×3 교차설계법에 의한 생물학적 동등성 시험을 인정하기로 하였다. 이에 이영주 등 (1998)은 온단세트론 제제에 대한 생물학적 동등성시험에서 3×3 교차설계법을 적용하였다. 그러나 오현숙 등(1999)에 의하면 3×3 교차설계법에서 각각 순서에 피험자의 수가 다르거나 실험 중에 결락(dropout)되는 피험자가 발생하는 경우에는 일반적인 통계적 방법을 적용하기 어려웠다. 이에 본 연구에서는 이러한 경우에 제제효과의 추론과 생물학적 동등성 시험에 대한 통계적 방법에 대해 논의하였다. In recent years, the generic drug products which provide the same therapeutic effect with an innovator drug product have become very popular in pharmacokinetic area. Since assessing bioequivalence of a generic drug with the innovator is required prior to distribution in markets, bioavailablity/bioequivalence studies in comparing several generic drugs simultaneously with the innovator is highly interested. In such circumstance, the Korean Drug Administration announces officially the partial acceptance regulation for the bioequivalence with the results from a 3 x 3 crossover designs when the generic drugs which contain same active ingredients and are produced by a same company are compared with the innovator in an experiment. Lee et a1.(1998), motivated from this new policy, try to assess hioequivalence of Ondensetron drugs using the 3 X 3 latin squares. In bioavailability and bioequivalence studies, the observed data set from a 3 x 3 cross-over design is unbalanced so that standard statistical methods for a cross-over design may not apply drectly. For drug and period effects, we propose a method based on differences of the observations that eliminates the random subject effects and thus does not require any distributional condition on the random subject effects.

생물학적 동등성 시험의 통계적 방법들의 비교 연구

박상규,임남규,이용흔 중앙대학교 수학통계연구소 2000 수학통계논문집 Vol.- No.7

Statistiscal methods for assessing of bioequivalence in 2×2 crossover design are discussed and compared with KFDA criterion. Simulation study for this comparison is conducted and summarized. The simulation result suggests that KFDA should reconsider the current guidelines for bioequivalence. Keywords - Bioequivalence, Crossover design, Power approach

폐석고와 Fly Ash를 재활용한 차수재의 배합비 산정을 위한 연구

이종우,권혁,임남웅,박규홍 중앙대학교 건설환경연구소 2000 環境科學硏究 Vol.11 No.2

This study was conducted to estimate experimentally the optimal mixing ratio of landfill liner materials using waste plaster and fly ash. Feasibility of reuse of waste plaster and fly ash was investigated as well as the use of cement, soil, and natural bentonite as landfill liner materials. Soil property index tests and compaction tests were performed to see the property of the soil used in this study. After selected materials were mixed with varied mixing ratio, hydraulic conductivity tests and unconfined compressive strength tests were conducted to see whether new liners using waste materials could meet the criteria as landfill liner regulated by the government. The optimal mixing was suggested as 30% of fly ash, 60% of soil used in this study, 3% of cement, 7% of bentonite to obtain 9.8×10-8 ~1.1×10-6 cm/sec of hydraulic conductivity and 6.2~15.2kg/cm2 of compressive strength.

상관계수검정에서 Score 검정

이은구,김정일,임남규 대전대학교 기초과학연구소 1996 自然科學 Vol.7 No.2

단순상관계수는 두변수간의 선형적인 연관관계를 나타내는 모수이다. 즉, 이는 두변수에 대해 얻어진 값들이 선형함수를 나타내는 직선의 주변에 어느정도 집중되어 있는지를 의미한다. 이러한 단순상관계수를 어느정도 집중되어 있는지를 측정함을 의미한다. 이러한 단순상관수를 검정함에 있어서 귀무가설이 ρ가 0일때는 표본상관계수 R의 함수가 t-분포를 따름을 이용하여 그 기각역을 구하였고, ρ가 0이 아닐 때에는 Fisher(1921)의 근사검정방법인 z-검정을 이용하였다. 그러나 본 연구는 상관계수검정을 Cox & Hinkley(1974)가 제안한 근사검정방법인 Score 검정에 응용하여 모의실험방법으로 위의 검정방법들과 비교하였다. The simple correlation coefficient is a statistical parametor for concerning linear relationship between two random variables. It measures the degree of concentration in samples around a linear function. When we test null hypothesis ρ=0, we derive critical regions based on the fact that the function of sample correlation coefficient follows t-distribution. On the other hand, if the null hypothesis ρ=ρo(≠0) we may use Fisher's z-test(1921). In this article we have applied score test (Cox & Hinkley (1974)) to testing correlation. We have compared the powers of score test with those of t-test and Fisher's z-test with respect to the method of simulation.

Predicting the Risk of Incident Hypertension in a Korean Middle-Aged Population: Korean Genome and Epidemiology Study

Lim, Nam-Kyoo,Son, Kuk-Hui,Lee, Kwang-Soo,Park, Hyeon-Young,Cho, Myeong-Chan Wiley Blackwell (Blackwell Publishing) 2013 The journal of clinical hypertension Vol.15 No.5

Statistical Analysis of Bioequivalence Study in 2x3 Cross-over Design

Lim, Nam-Kyoo 한국통계학회 2001 Communications for statistical applications and me Vol.8 No.2

The 2x3 cross-over design is proposed for the bioequivalence of two test drug formulations with a reference drug formulation. Oh et al.(1999) and Park et al.(1998) derived 3x2 cross-over design and discussed its benefits, since the 3x3 cross-over design may not be of practical design. We discuss the statistical issues for2x3 cross-over design and show its statistical properties. Bioequivalence problem in 2x3 cross-over design is considered statistically and an illustrated example is given.

Risk prediction for 30-day heart failure-specific readmission or death after discharge: Data from the Korean Acute Heart Failure (KorAHF) registry

Lim, Nam-Kyoo,Lee, Sang Eun,Lee, Hae-Young,Cho, Hyun-Jai,Choe, Won-Seok,Kim, Hokon,Choi, Jin Oh,Jeon, Eun-Seok,Kim, Min-Seok,Kim, Jae-Joong,Hwang, Kyung-Kuk,Chae, Shung Chull,Baek, Sang Hong,Kang, Seo Elsevier 2019 Journal of cardiology Vol.73 No.2

<P><B>Abstract</B></P> <P><B>Background</B></P> <P>Identifying patients with acute heart failure (HF) at high risk for readmission or death after hospital discharge will enable the optimization of treatment and management. The objective of this study was to develop a risk score for 30-day HF-specific readmission or death in Korea.</P> <P><B>Methods</B></P> <P>We analyzed the data from the Korean Acute Heart Failure (KorAHF) registry to develop a risk score. The model was derived from a multiple logistic regression analysis using a stepwise variable selection method. We also proposed a point-based risk score to predict the risk of 30-day HF-specific readmission or death by simply summing the scores assigned to each risk variable. Model performance was assessed using an area under the receiver operating characteristic curve (AUC), the Hosmer–Lemeshow goodness-of-fit test, the net reclassification improvement (NRI), and the integrated discrimination improvement (IDI) index to evaluate discrimination, calibration, and reclassification, respectively.</P> <P><B>Results</B></P> <P>Data from 4566 patients aged ≥40 years were included in the analysis. Among them, 446 (9.8%) had 30-day HF-specific readmission or death. The final model included 12 independent variables (age, New York Heart Association functional class, clinical history of hypertension, HF admission, chronic obstructive pulmonary disease, etiology of cardiomyopathy, systolic blood pressure, left ventricular ejection fraction, serum sodium, brain natriuretic peptide, N-terminal prohormone of brain natriuretic peptide at discharge, and prescription of β-blockers and angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists at discharge). The point risk score showed moderate discrimination (AUC of 0.710; 95% confidence interval, 0.685–0.735) and good calibration (<I>χ</I> <SUP>2</SUP> =8.540, <I>p</I> =0.3826).</P> <P><B>Conclusions</B></P> <P>The risk score for the prediction of the risk of 30-day HF-specific readmission or death after hospital discharge was developed using 12 predictors. It can be utilized to guide appropriate interventions or care strategies for patients with HF.</P> <P><B>Highlights</B></P> <P> <UL> <LI> The risk of 30-day heart failure (HF) readmission or death can be estimated with 12 variables. </LI> <LI> The risk for short-term HF-specific readmission or death can be calculated easily. </LI> <LI> The model has the potential to reduce readmission by identifying high-risk patients. </LI> <LI> The risk model can be utilized to guide suitable interventions or care in patients. </LI> </UL> </P>

Validation of the Korean Genome Epidemiology Study Risk Score to Predict Incident Hypertension in a Large Nationwide Korean Cohort

Lim, Nam-Kyoo,Lee, Joung-Won,Park, Hyun-Young UNKNOWN 2016 CIRCULATION JOURNAL Vol.80 No.7

<P>Background: This study aimed to validate the Korean Genome Epidemiology Study (KoGES) risk score to predict the 4-year risk of hypertension (HT) in a large nationwide sample, and compare its discrimination and calibration with the Framingham and blood pressure (BP)-only models. Methods and Results: This study analyzed 69,918 subjects without HT at baseline from the National Sample Cohort in the National Health Insurance Service database. We compared the Framingham, KoGES, and BP-only models for discrimination using area under the receiver-operating characteristic curves (AROC), calibration using goodness-of-fit tests, and reclassification ability using the continuous net reclassification improvement (NRI) and integrated discrimination improvement. Of 69,918 subjects, 18.6% developed HT during the follow-up. AROC was significantly higher for the KoGES (0.733) than for the Framingham (0.729) or BP-only (0.707) model. Recalibrated Framingham model underestimated HT incidence in all deciles (P<0.001). BP-only model overestimated risk in the lower deciles (P<0.001). KoGES model accurately predicted risk in all except the highest decile (chi(2)=14.85, P=0.062). The KoGES model led to a significant improvement in risk reclassification compared with the Framingham and BP-only models (NRI, 0.354; 95% confidence interval [CI], 0.343-0.365 and 0.542; 95% CI, 0.523-0.561, respectively). Conclusions: In this validation study, the KoGES model demonstrated better discrimination, calibration, and reclassification ability than either the Framingham or BP-only model. The KoGES model may help identify Korean individuals at high risk for HT.</P>

2011 대구 세계육상선수권대회 여자 장대높이뛰기경기 기술의 운동학적 분석

최규정 ( Kyoo Jeong Choi ),이경옥 ( Kyung Ok Yi ),김남희 ( Nam Hee Kim ),강지은 ( Ji Eun Kang ),김혜림 ( Hye Lim Kim ) 한국운동역학회 2011 한국운동역학회지 Vol.21 No.5

The purpose of this study was to perform the kinematic analyses of the women`s pole vault skills in IAAF World Championships Daegu 2011. Subjects were the 1st through 8th place finishers in the pole vault. The kinematic analyses were divided into four phases: two dimensional run up analysis, and three dimensional analyses for the remaining plant, swing up, and extension phases. Run-up variables consisted of run up distance, number of steps, average step length, ratio of step length to height, average velocity at the final 5~10 m, approach position. Three variables were analyzed during plant: pole angle, center of gravity (COG) velocity, and COG takeoff angle. Swing up phase variables included: pole flection angle, COG velocity (horizontal, vertical, resultant), COG trajectory and bar approach angle of COG. Compared to the 2009 World Championships in Berlin, the average vault height increased, while run up velocity and approach position were almost unchanged. However, horizontal velocity during the last two steps of the final approach decreased noticeably compared to speeds from 1990. These results reflect the change in both technique and physical fitness in pole vaulters. During extension, the peak height of COG surpassed the clearance height by an average of 0.11m. These specific results can help coaches and athletes modify training and improve performance.

2011 대구 세계육상선수권대회 여자 장대높이뛰기 경기 참가선수 경기기술의 운동학적 요인 비교분석

최규정 ( Kyoo Jeong Choi ),이경옥 ( Kyung Ok Yi ),김남희 ( Nam Hee Kim ),강지은 ( Ji Eun Kang ),김혜림 ( Hye Lim Kim ),문제헌 ( Je Heon Moon ),정범철 ( Bum Chul Jung ) 한국운동역학회 2013 한국운동역학회지 Vol.23 No.3

The purpose of this study was to compare the kinematic analyses of the women`s pole vault skills difference between skilled group (1st to 8th place) and less skilled group (10th to 15th place) who participated in IAAF World Championships Daegu 2011. To achieve this goal, 16 women`s pole vault player`s kinematic analyses was conducted. Player`s best performance was recorded by five normal video cameras operating at 60 Hz. The results of this study through the research procedures above are as follows. First, Skilled group`s average step length and the ratio of step length to her height were longer than less skilled`s group in runup phase. Second, Skilled group`s horizontal velocity was faster than less Skilled group`s results. And pole plant angle was lower than less Skilled group`s results in take-off phase. Third, Maximum pole flexion angle did not show difference of between two groups in pole bending phase. However, Skilled group`s vertical velocity was higher than less skilled group`s results.