• 제목/요약/키워드: Biological potency

검색결과 101건 처리시간 0.028초

Estimation of Relative Potency with the Parallel-Line Model

  • Lee, Tae-Won
    • 응용통계연구
    • /
    • 제25권4호
    • /
    • pp.633-640
    • /
    • 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).

생리활성과 분자구조의 상관관계에 관한 연구 (The Studies in Relationship between Molecular Structure and Biological Activities)

  • 김의락;민경섭;김종토;정봉진
    • 대한화학회지
    • /
    • 제37권1호
    • /
    • pp.68-75
    • /
    • 1993
  • 분자구조를 기술하는 molecular connectivity index, Wiener index 및 ad hoc descriptor와 알코올, 에스테르, 케톤 화합물들이 생체내에서 나타내는 enzyme inhibitory potency, lipoxygenase inhibition, tadpole narcosis potency, 증기독성(vapor toxicity), 증발열(heat of vaporization)과 같은 성질들 사이의 상관관계를 조사하였다. 생물학적 활성의 종류에 따라 molecular descriptor 사이의 우열은 있으나, 대체로 좋은 상관관계식을 얻었다.

  • PDF

Post HCV Infection Due to MX Gene Stimulation Produced Post Treatment with Imported and Locally Produced Egyptian Biosimilar IFN

  • Mohamed, Shereen H;Mahmoud, Nora F;Mohamed, Aly F;Kotb, Nahla S
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제16권14호
    • /
    • pp.5635-5641
    • /
    • 2015
  • Background: Cirrhosis is regarded as a possible end stage of many liver diseases, including viral infection. It occurs when healthy liver tissue becomes damaged and is replaced by scar tissue and finally may lead to hepatocellular carcinoma. Interferons (IFNs)are two general categories, type I and II. Type I includes one beta interferon and over 20 different alpha interferons. Alpha interferons are very similar in how they work, interacting with other proteins on cells like receptors. The main objective of this study was to compare Mx gene productivity post different cell line treatment with imported and Egyptian biosimilar locally produced IFNs, as well as the efficacy of those tested IFNs. Also, an assessment was made of sensitivity of different cell lines as alternatives to that recommended for evaluation of antiviral activity. Materials and Methods: Different cell lines (Vero, MDBK and Wish) were employed to evaluate cytotoxicity using the MTT assay. Antiviral activity was evaluated compared with standard IFN against VSV, Indiana strain -156, on tested rh-IFNs (imported; innovated and Egyptian biosimilar locally produced IFNs) in the pre-treated cell lines previously mentioned. The virus was propagated in the Wish cell line as recommended. Finally we estimated up-regulation of the Mx gene as a biomarker. Results: Data recorded revealed that test IFNs were safe in test cell lines. Viability was around 100%. Locally tested interferon did not realize the international potency limits, while the imported one was accepted compared with the standard IFN. These results were the same either using infectivity titer reduction assay or crystal violet staining of residual non- infected cells. Mx protein production was cell type related and confirmed by the detected Mx gene expressed in imported and locally produced IFN pre-treated cell lines. The expression of the gene was arranged in the order of Vero> wish > MDBK for the imported IFN, while for the Egyptian biosimillar locally produced one it was MDBK> Vero> wish. With regard to the antiviral activity there was a significant difference of imported IFN potency compared with the locally produced IFN (P<0.05), the IFN potential (antiviral activity) was not cell line related and showed non-significant difference for each separate product. Conclusions: Vero cells can be used as an alternative cell line for evaluation of IFN potency in case of unavailable USP recommended cell lines. Alternative potency evaluation assay could be used and proved significant difference in IFN potency in case of local and imported agents. Evaluation of antiviral activity could be used in parallel to viral infectivity reduction assay for better accuracy. Mx gene can be used as a marker for IFN potential.

Antimutagenic and Anticarcinogenic Potency of Green Tea(Camellia sinensis)

  • Kinae, Naohide
    • 한국독성학회:학술대회논문집
    • /
    • 한국독성학회 2003년도 추계학술대회
    • /
    • pp.94-94
    • /
    • 2003
  • Tea is the most popular beverage in the world, especially green tea (Camellia sinensis) is daily taken by Asian people including Japanese. In last two decades, a variety of biological effects of tea components such as antioxidative, antimutagenic, anticarcinogenic, antibacterial and radical scavenging activities on bacteria, cultured cells and mammals have been elucidated.(omitted)

  • PDF

재조합 사람성장호르몬(소마트로핀)의 KFDA 표준품(KS 98/674) 설정 연구 (Collaborative Study for the Establishment of KFDA Reference Standard for Somatropin (KS 98/674))

  • 신원;정지원;진재호;;손여원
    • 약학회지
    • /
    • 제45권2호
    • /
    • pp.227-236
    • /
    • 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.

  • PDF

A Collaborative Study to Establish a Korea National Biological Standard for Antithrombin Concentrate

  • Kang, Hye-Na;Lee, Sung-Han;Kim, Soon-Nam;Hong, Choong-Man;Lee, Ki-Hong;Oh, Ho-Jung;Yoo, Si-Hyung;Shin, In-Soo;Choi, Seung-Eun;Lee, Seok-Ho;Gray, Elaine;Okada, Yoshiaki;Hong, Seung-Hwa
    • 대한약학회:학술대회논문집
    • /
    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
    • /
    • pp.272.1-272.1
    • /
    • 2002
  • We have carried out collaborative study to evaluate a preparation of antithrombin concentrate whether or not it was suitable to serve as the candidate for a Korea National Biological Standard. Six laboratories. including three manufacturers and three National Control Laboratories. participated in this study. The potency of this candidate preparation was determined using the heparin cofactor chromogenic method. (omitted)

  • PDF

생물학적활성을 기초로 한 테트라싸이클린계 항생물질 잔류스크리닝법의 개선과 식품 중 잔류허용기준 설정 개선 (Epimers/Metabolites of Tetracycline Derivatives; Biological Activity and Regulation Aspects for MRL in Food)

  • 권진욱;윤효인;이규승
    • 한국환경농학회지
    • /
    • 제30권1호
    • /
    • pp.82-88
    • /
    • 2011
  • 현재 우리나라에서 널리 이용되고 있는 미생물학적 검사법을 이용하여 TCs 계열의 모화합물과 epimer에 대한 검출 그리고 이를 통한 모화합물과 epimer간의 상대적 생물학적 활성도를 확인하였다. 시험법의 관점에서 낮은 선택성과 낮은 민감도를 나타낸 균주는, 다양한 적용 가능 균주의 발굴 및 적용이 시험법 검증을 통해 이루어질 필요가 있다. 극단적으로 식품 중 epimer만이 잔류하여 미생물 시험에서 의양성이 나올 경우, 기기분석을 통해 확인 정량시 원물질이 검출되지 않는다면, 이는 분석화학과 독성학의 과학적 지식을 바탕으로 볼 때 제도적 맹점으로도 남을 수도 있다. 그리고, 현행 우리나라의 모화합물에 국한 된 잔류허용 기준은 활성이 있는 epimer나 대사산물까지 확대하여 검토 해 볼 필요가 있으며, 이는 최근 의약품류의 환경 중 잔류실태 조사, 환경 중 위해성 평가 및 관리를 위해서도 관리 대상물질을 과학적 근거에 따라 제시해 주는 중요한 자료가 된다.

고상법에 의한 Dermorphin 유사체의 합성과 생물학적 활성에 관한 연구 (Synthesis of Dermorphin Analogues by the Solid Phase Method and Biological Activity)

  • 한만소
    • 한국응용과학기술학회지
    • /
    • 제19권4호
    • /
    • pp.281-290
    • /
    • 2002
  • Dermorphin is a hepta peptide(H-Tyr-DAla-Phe-Gly-Tyr-Pro-Ser-$NH_{2}$)with exceptionally potent and long-lasting peripheral and central activity. Dermorphin analogues, dermorphionyl(DMP)-Lys-$NH_{2}$ and DMP-Lys-Lys-$NH_{2}$ have been prepared in order to examine the effect of opiod activity. Dermorphin analogues were synthesized by the solid phase method. The crude peptide was purified by gel filter on a Sephadex LH-20, characterized with HPLC and amino acid analyzer. Analgesic potency was estimated by writhing syndrome method and Randall-Selitto method. As a result, dermorphin analogues have lower potency than that of morphine.

Synthesis of Benzoxazole and Bezothiazole-linked TZD Analogs as PPARν Specific Ligands

  • Kim, Hae-Sung;Park, So-Yeon;Raok Jeon
    • 한국응용약물학회:학술대회논문집
    • /
    • 한국응용약물학회 2003년도 Annual Meeting of KSAP : International Symposium on Pharmaceutical and Biomedical Sciences on Obesity
    • /
    • pp.117-117
    • /
    • 2003
  • PPARs (peroxisome proliferator activated receptors) are member of nuclear hormone receptors superfamily. Activations of PPARs upon binding with ligands modulate glucose metabolite, differentiation of adipocyte, inflammation response, and so on. Thiazolidinedione analog is one of potential antidiabetic drug that binds and activates PPARν selectively and enhances insulin sensitivity. In an effort to develop novel and effective antidiabetic thiazolidindione analogs, syntheses of benzoxazole and benzothiazole-linked thiazolidinedione analogs were performed via coupling reaction of benzoxazolylalkylaminoethanol with hydroxybenzylthiazolidinedione to develop novel and effective antidiabetic thiazolidindiones. All compounds were evaluated their biological potency by PPARν transactivation assay and revealed the similar potency with Troglitazone. However, lengthening of N-alkyl substituent did not seem to be beneficial for the activity.

  • PDF

Prediction of Parathyroid Hormone Signalling Potency Using SVMs

  • Yoo, Ahrim;Ko, Sunggeon;Lim, Sung-Kil;Lee, Weontae;Yang, Dae Ryook
    • Molecules and Cells
    • /
    • 제27권5호
    • /
    • pp.547-556
    • /
    • 2009
  • Parathyroid hormone is the most important endocrine regulator of calcium concentration. Its N-terminal fragment (1-34) has sufficient activity for biological function. Recently, site-directed mutagenesis studies demonstrated that substitutions at several positions within shorter analogues (1-14) can enhance the bioactivity to greater than that of PTH (1-34). However, designing the optimal sequence combination is not simple due to complex combinatorial problems. In this study, support vector machines were introduced to predict the biological activity of modified PTH (1-14) analogues using mono-substituted experimental data and to analyze the key physicochemical properties at each position that correlated with bioactivity. This systematic approach can reduce the time and effort needed to obtain desirable molecules by bench experiments and provide useful information in the design of simpler activating molecules.