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2 X 2 교차설계법에서 모집단 생물학적 동등성 검정 방법 비교
박상규,임남규,이재영,김병천,Park Sang-Gue,Lim Nam-Kyoo,Lee Jae-Young,Kim Byung-Chun 한국통계학회 2005 응용통계연구 Vol.18 No.1
최근 미국을 위시한 선진국에서 제제간의 생물학적 동등성을 판단하는 기준이 생체 이용률의 평균치를 비교하는 시험에서 분산까지 같이 고려하는 기준으로 바뀌고 있다. 처방성과 교차사용성을 의미하는 모집단과 개인 생물학적 동등성이 바로 그것이다. US FDA에서는 2 × 4 교차설계법을 활용해서 제제간의 생동성을 입증하는 것을 추천하고 있다. 현재 US FDA에서 제안하고 있는 모집단 생물학적 동등성 평가 방법은 통계적으로 문제점을 가지고 있어 최근 Lee, Shao & Chow(2002), Chow, Shao & Wang(2003), 그리고 McNally, Iyer & Mathew(2002)에 의해서 수정된 평가 방법들이 제안되고 있다. 본 연구 논문에서는 그동안 제제간의 생물학적 동등성 평가 설계법이였던 2×2 교차설계법을 이용해서 모집단 생물학적 동등성을 평가하는 방법을 논의하고 최근 제안된 방법들을 모의실험을 통해 비교하여 가장 적절한 방법론을 제안한다. The US Food and Drug Administration(FDA) recommends that population bioequivalence and individual bioequivalence would be assessed to address the prescribability and switchability between a brand-name drug and its new formulation or generic copy in its 2001 guidance document. The test for population bioequivalence in the latest FDA guidance is recommended in 2 x 4 crossover design, but it turns out to be very conservative. Recently Lee, Shao & Chow(2002), Chow, Shao & Wang(2003) and McNally, Iyer & Mathew(2002) proposed new statistical methods for assessing population bioequivalence between drugs to correct the biasness of current FDA method. Since 2 x 2 crossover experiment is most welcomed design in bioequivalence testing, we adopt their methods to 2 x 2 crossover designs and compare their methodologies with FDA one through the simulation study.
박상규,남봉현,정윤노,이재영,정규진,Park, Sang-Gue,Nam, Bong-Hyun,Chung, Yun-Ro,Lee, Jae-Young,Jeong, Gyu-Jin 한국통계학회 2010 Communications for statistical applications and me Vol.17 No.1
제제간의 생물학적 동등성을 입증하는데 실패했을 때 추가시험을 허용하는 새로운 생물학적 동등성 시험 기준이 2008년 7월부터 시행하게 되었다. 추가시험의 의미나 시험 기준에서 제시하는 절차를 살펴보고 추가시험의 통계학적 의미를 고찰한다. 또한 사례를 통해 추가시험을 고려할 경우 어떤 점에 유의하여야 성공 할 수 있을 것인가 논의한다. The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 and some discussion from statistical point of view would be needed for a practical use. The statistical model of add-on test is introduced and its two stage testing procedures are discussed. Meaningful statistical points of the add-on test are delivered through an illustrated example.
2 × 2 교차설계에 의한 생물학적동등성시험에서 결측치가 있을 때의 통계적 해석 방법
박상규,이재영,최성업,윤미경,이재휘,최영욱,Park, Sang-Gue,Lee, Jae-Young,Choi, Sung-Up,Yoon, Mi-Kyeong,Lee, Jae-Whi,Choi, Young-Wook 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
Statistical interpretations in a bioequivalence trial are considered and studied when the missing observations occurred in $2\;{\times}\;2$ crossover experiment. Patel (1985) suggested the approximate test procedures for carryover effect and drug effect in $2\;{\times}\;2$ crossover design when some of data are missing in the second period. A modified Patel method is newly proposed to the bioequivalence trial and it is compared with the current method through the simulation study.
$3{\times}2$ 교차설계법에서 생물학적 동등성 시험의 통계분석
박상규,김정일,채성산,고승곤,오현숙,양완연,김동섭,최영욱,Park, Sang-Gue,Kim, Jeong-Il,Chae, Sung-San,Ko, Seoung-Gon,Oh, Hyun-Sook,Yang, Wan-Youn,Kim, Dong-Sup,Choi, Young-Wook 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.4
A $3{\times}2$ crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over $3{\times}3$ crossover design because of the cost and experimental duration. Oh et al.(1998) derived $3{\times}2$ crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for $3{\times}2$ crossover design and show its statistical properties. The statistical procedures for the bioequivalence in $3{\times}2$ crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.
박상규(Sang Gue Park),김정일(Jeong Il Kim),채성산(Sung San Chae),고승곤(Seoung Gon Ko),오현숙(Hyun Sook Oh),양완연(Wan Youn Yang),김동섭(Dong Sup Kim),최영욱(Young Wook Choi) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.4
N/A A 3×2 crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over 3×3 crossover design because of the cost and experimental duration. Oh et al.(1998) derived 3×2 crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for 3×2 crossover design and show its statistical properties. The statistical procedures for the bioequivalence in 3×2 crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.
기저치를 가진 생물학적 동등성 평가의 통계적 고찰: 내인성 제제 사례연구
박상규 ( Sang-gue Park ),김상영 ( Sangyoung Kim ) 한국보건정보통계학회(구 한국보건통계학회) 2018 한국보건정보통계학회지 Vol.43 No.2
Objectives: To assess bioequivalence between two endogenous drugs in 2 × 2 crossover trial with baseline measurements. Methods: Two statistical methods are applied to assess bioequivalence between two endogenous drugs in 2 × 2 crossover trials. The first method is based on the current regulatory guideline published by Ministry of Food and Drug Safety (MFDS), which is based on the difference between baseline measurements and responses. The second method is more general approach, so-called general linear model method, which is defined the baseline measurements as covariates. Results: The first method based on current guideline shows that two drugs are not bioequivalent; however, the second method by general linear model shows that two drugs are bioequivalent. When the baselines of the subjects are expected to be highly variable, general linear model approach is more suitable to assess the bioequivalence by adjusting high subjects’ variations. Conclusions: General linear model with covariates should be considered in assessing bioequivalence of endogenous substances when highly subject variations of baseline measurements are expected.
정규진,박상규,Jeong, Gyu-Jin,Park, Sang-Gue 한국통계학회 2011 응용통계연구 Vol.24 No.6
본 논문에서는 변이가 큰 약물(HVD)의 생동성 평가 문제와 이를 해결하기 위하여 지금까지 수행된 연구 결과들을 소개한다. 우리나라를 비롯한 세계 여러 나라에서 현재 사용하는 전통적 생동성 평가규정 중에서 HVD에 적용 가능한 방법들과 HVD 문제 해결을 주된 목적으로 고안된 방법들로 나누어 살펴본다. 특히 scaled average bioequivalence(SABE)에 대한 연구 결과들을 통계학적인 관점에서 검토하며 SABE를 이용하여 수행하는 생동성 평가 방법에 대해 알아보고 추후 연구주제 등에 대해서도 논의한다. This paper reviews the definition of highly variable drug(HVD), the present regulatory recommendations and the approaches proposed in the literature to deal with the bioequivalence issues of HVD. The concept and the statistical approach of scaled average bioequivalence(SABE) is introduced and discussed with the current regulatory methods. The recommendations for SABE approach are proposed and the further study topics related to HVDs are also presented.