• 응용통계연구
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• 제25권4호
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• pp.633-640
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• 2012

Biological methods are described for the assay of certain substances and preparations whose potency cannot be adequately assured by chemical or physical analysis. The principle applied through these assays is of a comparison with a standard preparation to determine how much of the examined substance produces the same biological effects as a given quantity (the Unit) of the standard preparation. In these dilution assays, to estimate the relative potencies of the unknown preparations to the standard preparations, it is necessary to compare dose-response relationships of standard and unknown preparations. The dose-response relationship in the dilution assay is non-linear and sigmoid when a wide range of doses is applied. The parallel line model (applied to the dose region with the steepest slope) is used to estimate the relative potency. In this paper, the statistical theory in the parallel line model is explained with an application to a dilution assay data. The parallel line method is implemented in a SAS program and is available at the author's homepage(http://cafe.daum.net/go.analysis).

• 한국환경과학회지
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• 제13권6호
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• pp.591-597
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• 2004

In this study, sixty chemicals including 47 pesticides were screened for estrogenic activity using E-screen assay. MCF-7 cell, used in E-screen assay, is known to be proliferated by addition of estrogenic chemicals. Eight of the measured pesticides showed estrogenic activity at the concentration range of 100-10,000nM. Their relative proliferative effect (RPE) and the relative proliferative potency (RPP) were 20-65% and 0.01-1.0%, respectively, when compared with 1.0nM of $\beta-Estradiol-17-acetate(E_{2}).$ DDVP and diazinone showed most strong estrogenic potency(RPP; 1.0%) and effect(RPE; 65%) of the eight pesticides. These results are in agreement with estrogenic activity of bisphenol A is known as a positive endocrine disrupter. Also, in this study, paraquat, DDVP, 4-chloro-3-methylphenol, 2,4,6-trichlorophenol and diazinon of the measured pesticides are estimated to estrogenic chemical.

• Journal of Microbiology and Biotechnology
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• 제14권4호
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• pp.745-750
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• 2004

The objective of this collaborative study was to establish a Korean standard of Japanese encephalitis (JE) vaccine (mouse brain-derived, formalin-inactivated) for potency assay. A candidate preparation proposed as a Korean standard was provided by GreenCross Vaccine, and six laboratories, including one national control laboratory and five manufacturers of JE vaccine, participated in the study. The potency of the candidate preparation and a reference standard obtained from Japan was estimated by mouse immunogenicity assay using the in vitro plaque reduction neutralization test (PRNT). The results of 72 assays conducted by the 6 laboratories showed that the overall mean potency estimate of the candidate preparation was 2.455 log median plaque reduction neutralization antibody titer per 0.5-ml dosage administered twice in mice at 7-day intervals, and that the mean potency ratio of the candidate preparation relative to the reference standard was 1.074. The potency estimates were quite variable among laboratories irrespective of the preparation. The variability of assays assessed by Z scores and coefficient of variation (CV) were in general within the level of acceptance (Z scores within $\pm3$ and $CV\;\leq\;15%$). Therefore, we concluded that the candidate preparation would be suitable as a national standard for testing the potency of JE vaccine (inactivated).

• 약학회지
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• 제45권2호
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• pp.227-236
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• 2001

The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone (somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control (NIBSC). The candidate KFDA reference standard for somatropin (designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01 mg somatropin per ampoule. Data from the study also yielded mean values of 0.39 $\pm$ 0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 $\pm$ 1.29% for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 aganist IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.

• Toxicological Research
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• 제16권2호
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• pp.141-146
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• 2000

Phthalate esters are used extensively as a plasticizer in the manufacture of plastic products such as PVC bags and medical devices. Recently, phthalate esters have been shown to induce endocrine system mediated responses. However. only a Jew studies have been conducted for estrogenic activity of phthalate esters. In this study estrogenic activities of seven phthalate esters. butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), di-n-butylphthalate (DBP), diethylphthalate (DEP), di-n-pentylphthalate (DPP), di-n-propylphthalate (DPrP) and dicyclohexylphthalate (DCHP), were examined in vitro using E-screen assay and competitive binding assay. From the E-screen assay, BBP. DEHP. DBP and DEP showed weak estrogenic activity at the concentration of 5 $\mu\textrm{M}$. The relative proliferative effect (RPE) and the relative proliferative potency (RPP) were 50~70% and 0.01%. respectively, when compared with 500 pM of 17$\beta$-estradiol (E2). In competitive binding assay with the rat uterine estrogen receptor (ER), BBP and DEP showed weak binding potency ［(l/$10^4$~1/$10^5$ of E2］ while DEHP and DBP scarcely bound to ER. These results suggest that some phthalate esters have weak estrogenic activities in vitro.

• 한국식품과학회지
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• 제49권1호
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• pp.63-71
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• 2017

This study aimed to assess the antioxidative potential of adding ethanolic extracts from Ulmus davidiana to Yackwa (Korean fried cookie). The reducing power and antioxidant activity of U. davidiana-treated Yackwa were assessed against DPPH, nitric oxide, superoxide anions, superoxide dismutase, and ABTS radicals. Increasing the amount of U. davidiana extract in Yackwa dough resulted in improved antioxidant properties. U. davidiana extracts were effective antioxidants with a radical scavenging potency similar to the potency of butylated hydroxytoluene (BHT) and L-ascorbic acid. The DPPH and nitric oxide radical scavenging activity of Yackwa containing 0.2% U. davidiana resulted in increased oxidative stability relative to control dough. Although the antioxidant effects of Yackwa containing U. davidiana extract were lower than those of Yackwa containing BHT and L-ascorbic acid, these results suggest that U. davidiana extracts have potent antioxidant activity. Accordingly, U. davidiana extract is a potential additive for deep-fried foods, such as Yackwa, to improve their oxidative stability.

• Communications for Statistical Applications and Methods
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• 제3권3호
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• pp.179-186
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• 1996

Bioequivanence models arise typically in bioassays when new preparations are compared against standard ones by means of responses on some biological organisms. Relative potency measures provide nice interpretations for such bioequivalence and their estimation constitutes the prime interest of such studies. A conditional quantile process based on the k-nearest neighbor method is proposed for this purpose. An alternative procedure based on Kolmogrov-Smirnov type estimator has also been considered along with. ARIC ultrasound data are analyzed as examples.

• 식물조직배양학회지
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• 제21권2호
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• pp.123-129
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• 1994

대두(Glycine max L) 자엽의 발아 정도에 따른 부정근 형성능과 자엽 절편의 부정근 형성 배지 처리 시간에 따른 부정근 형성 정도를 조사하였으며 부정근 형성과 관계 있는 발아 및 부정근 유기시의 단백질 변화 양상을 2차원 전기영동법으로 조사하였다. 발아된 자엽의 부정근 형성능은 발아 4일 이후에 높았으며 부정근 형성 배지에서의 부정근 형성은 처리 4일 이후부터 형성되어 6일 이상 처리한 것이 가장 부정근 형성이 높았다. 또한 부정근 형성과 관계 있는 단백질 34개의 단백질 spot를 얻었는데 부정근 형성을 위한 발아 자엽의 주요 단백질은 염기성 단백질 27d이었다. 그리고 부정근 유기시 생성되는 단백질은 염기성의 길 kD, 23 kD 및 33 kD였으며 산성의 27 kD와 29 kD이었다.

• 생약학회지
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• 제37권1호통권144호
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• pp.21-27
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• 2006

Yeast based estrogenicity assay is the simplest and useful for the assay and the discovery of novel estrogenic substances in natural specimens, The estrogen receptor(ER) modulation activity of 50% EtOH extracts of 101 traditional medicinal herbs was assessed using a recombinant yeast assay system with both a human estrogen receptor expression plasmid and a receptor plasmid. Among them, 14 species proved to be active. Pureariae Flos (flower of Puerraria thunbergiana BENTH.) had the highest estrogenic relative potency$(7.75{\times}10^{-3})$ $(EC_{50}=9.39\;{\mu}g/ml)$. The $EC_{50}$ value of $17{\beta}-estradiol$ used as the positive control was $0.073\;{\mu}g/ml)$ (Relative Potency=1.00). There results demonstrated that some of the traditional medical herb may be useful in the therapy of estrogen replacement.

• 약학회지
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• 제37권4호
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• pp.397-407
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• 1993

The muscarinic antagonist l-[benzilic-4,4'-$^3H$]quinuclidinyl benzilate([$^3H$]QNB) bound to a single class of muscarinic receptor with high affinity in guinea pig ileal membranes. The $K_{D}$ and B$_{max}$ values for [$^3H$]QNB calculated from analysis of saturation isotherms were 54 pM and 156fmol/mg, respectively. H$_{1}$-blockers inhibited [$^3H$]QNB binding to ileal membranes with $K_{i}$ values ranged from 0.008 $\mu{M}$ to 1.6 $\mu{M}$. The pseudo-Hill coefficients of H$_{1}$-blockers for inhibition of [$^3H$]QNB binding to the ileal membranes were close to unit. The $K_{i}$ values for H$_{1}$-blockers were similar to the $K_{M}$ values calculated by Schild plot of functional data obtained from inhibition of the carbachol-induced contraction in guinea-pig ileum, suggesting that binding of H$_{1}$-blockers vs [$^3H$]QNB in ileal membranes represents an interaction with a receptor of physiological relevance. The $K_{H}$ values of H$_{1}$-blockers for H$_{1}$-receptor estimated from inhibition of the histamine-induced contraction were the range of 0.15 nM to 56.5 nM. The $K_{M}$/K$_{H}$ ratio of H$_{1}$-blockers varied over a wide range of 3 to 2300. Thus, the antihistaminic potencies of H$_{1}$-blockers do not correlate with their antimuscarinic potencies, which suggest that antihistamines have different antimuscarinic potencies in therapeutic blood levels causing similar antiallergic effect. Among 13 traditional antihistaminics examined in this study, drug having the highest and the lowest $K_{M}$/K$_{H}$ ratio is triprolidine and diphenidol, respectively. The present results demonstrate that the antimuscarinic property of antihistamines is not necessary for their antiallergic effect, and data on the affinity of antihistamines for muscarinic and H$_{1}$-receptors can be an important parameter in the selection and evaluation of these drugs.