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Simultaneous determination of kolliphor HS15 and miglyol 812 in microemulsion formulation by ultra-high performance liquid chromatography coupled with nano quantity analyte detector

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Journal of Pharmaceutical Analysis 2016年第1期6卷 11-17页

作者： Honggen Zhang ZhenyuWang Oscar Liu Merck Research Laboratories Merck & Co. Inc. Rahway NJ 07065 USA

A novel method for simultaneous determination of kolliphor HS15 and miglyol 812 in microemulsion formulation was developed using ultra-high performance liquid chromatography coupled with a nano quantitation analytical detector （UHPLC-NQAD）. All components in kolliphor HS15 and miglyo1812 were well separated on an Acquity BEH C18 column. Mobile phase A was 0.1% trifluoroacetic acid （TFA） in water and mobile phase B was acetonitrile. A gradient elution sequence was programed initially with 60% organic solvent, slowly increased to 100% within 8 min. The flow rate was 0.7 mL/min. Good linearity （r 〉 0.95） was obtained in the range of 27.6-1381.1 μg/mL for polyoxyl 15 hydroxystearate in kolliphor HS15, 0.8-202.0 μg/mL for caprylic acid triglyceride and 2.7-221.9μg/mL for capric acid triglyceride in miglyol 812. The relative standard deviations （RSD） ranged from 0.6% to 1.7% for intra-day precision and from 0.4% to 2.7% for inter-day precision. The overall recoveries （accuracy） were 99.7%-101.4% for polyoxyl 15 hydroxystearate in kolliphor HS15, 96.7%-99.6% for caprylic acid triglyceride, and 94.1%- 103.3% for capric acid triglyceride in miglyol 812. Quantification limits （QL） were determined as 27.6 μg/ mL for polyoxy115 hydroxystearate in kolliphor HS15, 0.8 μg/mL for caprylic acid triglyceride, and 2.7 μg/ mL for capric acid triglyceride in miglyol 812. No interferences were observed in the retention time ranges of kolliphor HSI5 and miglyol 812. The method was validated in terms of specificity, linearity, precision, accuracy, QL, and robustness. The proposed method has been applied to microemulsion for- mulation analyses with good recoveries （82.2%-103.4%）.

关键词： Kolliphor HS15 Miglyol 812 Ultra-high performance liquid chromato-graphy (UHPLC) Nano quantitation analytical detector(NQAD)

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Releasing Wolbachia-infected Aedes aegypti to prevent the spread of dengue virus: A mathematical study

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Infectious Disease Modelling 2020年第1期5卷 142-160页

作者： Hong Zhang Roger Lui Merck Research Laboratories RahwayNJ07065USA Department of Mathematical Sciences Worcester Polytechnic InstituteWorcesterMA01609USA

Wolbachia is a bacterium that is present in 60%of insects but it is not generally found in Aedes aegypti,the primary vector responsible for the transmission of dengue virus,Zika virus,and other human diseases caused by RNA *** has been shown to stop the growth of a variety of RNA viruses in Drosophila and in ***-infected *** have both reproductive advantages and disadvantages over wild *** Wolbachia-infected females are fertilized by either normal or infected males,the offspring are healthy and *** the other hand,if Wolbachia-negative females are fertilized by Wolbachia-positive males,the offspring do not *** phenomenon is called cytoplasmic ***,Wolbachia-positive females have a reproductive advantage,and the Wolbachia is expanded in the *** the other hand,Wolbachia-infected mosquitoes lay fewer eggs and generally have a shorter *** recent years,scientists have successfully released these Wolbachia-adapted mosquitoes into the wild in several countries and have achieved a high level of replacement with Wolbachiapositive ***,we propose a minimal mathematical model to investigate the feasibility of such a release *** model has five steady-states two of which are locally asymptotically *** of these stable steady-states has no Wolbachia-infected mosquitoes while for the other steady-state,all mosquitoes are infected with *** apply optimal control theory to find a release method that will drive the mosquito population close to the steady-state with only Wolbachia-infected mosquitoes in a twoyear time *** some of the model parameters cannot be accurately measured or predicted,we also perform uncertainty and sensitivity analysis to quantify how variations in our model parameters affect our results.

关键词： Mathematical modeling Steady-states Bistability Optimal control Uncertainty analysis Sensitivity analysis

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Quantitation of Genetox Impurities Using a Surrogate Standard Approach

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Journal of Analytical Sciences, Methods and Instrumentation 2013年第3期3卷 167-172页

作者： Heather Wang Regina Nardi Yuri Bereznitski Roy Helmy David J. Waterhouse Analytical Chemistry Merck Research Laboratories Merck Sharp & Dohme Corp. Rahway USA.

With the ever increasing complexity of active pharmaceutical ingredient (API) preparations, more potential genotoxic impurities (PGI’s) are being observed. It is thus necessary to determine if these PGI’s are present in the final API’s, and if they are present, to ensure the levels are acceptable for any clinical uses. For PGI’s that have authentic standards available, quantitation can be accomplished in a straightforward manner. However, for PGI’s that are expected to form through rearrangements or side reactions, authentic standards may not be readily available, significantly complicating the analysis. In this study we describe a surrogate standard approach for quantifying PGI’s that allows for relative response factor calculations of PGI species utilizing both gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS).

关键词： Potential Genotoxic Impurity (PGI) Active Pharmaceutical Ingredient (API) Mass Spectrometry Surrogate Standard Analyte Relative Response Factor (RRF)

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生物类似药的稳定性研究设计与分析(英文)

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药物分析杂志 2015年第5期35卷 793-802页

作者： Annpey Pong Shein-chung Chow Merck Research Laboratories Rahway New Jersey USA Duke University School of Medicine Durham North Carolina USA

生物制品对光线和温度等环境因素高度敏感,这些因素可能影响药物的质量和有效性。由于制造过程的各种差异,生物类似药只能与参比制品相类似。因此,为了确保生物类似药的活性在有效期内符合批准的标准规定,对其进行严格的稳定性测试至关... 详细信息

生物制品对光线和温度等环境因素高度敏感,这些因素可能影响药物的质量和有效性。由于制造过程的各种差异,生物类似药只能与参比制品相类似。因此,为了确保生物类似药的活性在有效期内符合批准的标准规定,对其进行严格的稳定性测试至关重要。本文介绍使用阵列式设计(matrix designs)与统计分析研究生物制品的长期稳定性特征。研究基于1/3和2/3的按时设计构建了阵列式设计,考察了强度、批次和包装等多种因素。阵列数据既可经检验进行合并性(poolability)分析,也可不经检验直接进行合并性分析。这些方法将有助于降低生物制品开发注册过程中稳定性和保质期研究的成本。

关键词：生物类似药模拟生物制品(follow-on biologics) 药品有效期货架期包围式设计(bracketing design) 阵列式设计

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Transformation Models for Survival Data Analysis with Applications

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Open Journal of Statistics 2016年第1期6卷 133-155页

作者： Yang Liu Qiusheng Chen Xufeng Niu Senior Biometrician Merck Research Laboratories Rahway NJ USA Department of Statistics Florida State University Tallahassee FL USA

When the event of interest never occurs for a proportion of subjects during the study period, survival models with a cure fraction are more appropriate in analyzing this type of data. Considering the non-linear relationship between response variable and covariates, we propose a class of generalized transformation models motivated by Zeng et al. [1] transformed proportional time cure model, in which fractional polynomials are used instead of the simple linear combination of the covariates. Statistical properties of the proposed models are investigated, including identifiability of the parameters, asymptotic consistency, and asymptotic normality of the estimated regression coefficients. A simulation study is carried out to examine the performance of the power selection procedure. The generalized transformation cure rate models are applied to the First National Health and Nutrition Examination Survey Epidemiologic Follow-up Study (NHANES1) for the purpose of examining the relationship between survival time of patients and several risk factors.

关键词： Link Functions Mixture Cure Rate Models Noninformative Improper Priors Proportional Hazards Models Proportional Odds Models

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Examining Pet Attitude in Relationship to Loneliness and Parenthood Motivation in Pet-Owning Adults

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Health 2014年第7期6卷 598-606页

作者： Cheryl A. Krause-Parello Yvonne Wesley Minnie Campbell College of Nursing Seton Hall University South Orange USA College of Nursing University of Colorado Denver Anschutz Medical Campus Aurora USA Independent Health Consultant Rahway USA

Pets’ growing role in family dynamics creates questions about resources pets may provide in parenthood motivation. Pet ownership has been suggested in the literature as an antecedent to parenthood in terms of developing skills needed to rear offspring, nurturance, and responsibility. Participants (N = 118) who were pet owners, completed an online survey that recorded demographics and consisted of loneliness, pet attitude, and parenthood motivation scales. Results supported that loneliness and pet attitude were positively related to parenthood motivation (all p’s < 0.05). Loneliness and parenthood motivation did not vary by pet species. Pet attitude varied by pet species;dog owners had the most positive attitude. Pets were shown to be a valuable resource in alleviating feelings of loneliness and parenthood preparation in this sample. Implications for nursing practice and future research are discussed.

关键词： Pet Attitude Loneliness Pets Parenthood

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How to Write a Medical Research Paper for an International Journal

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中国真菌学杂志 2010年第6期5卷 370-375页

作者： Glenn S.Bulmer Robert A.Fromtling Department of Dermatology/Research Center of Medical Mycology Peking University First Hospital Department of Biopharma University of Medicine and Dentistry of New JerseyNewarkNJUSA and MerckSharp & DohmeRahway

Western-raised scientists are taught with the traditional concepts of:purpose,method,observation and *** is not true for Chinese educated *** all international journals publish papers following these,or similar parameters,the Chinese scientist who wishes to publish in such a journal,must adjust his thinking to fit within this *** this presentation we wish to assist our Chinese colleagues on how this thought process can be followed.

关键词：医学教育书写格式期刊出版工作中国

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Evaluation of the Effect of Aspirin on Platelet Aggregation: Methodological Recommendations for Aspirin-Drug Interaction Studies

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Journal of Biomedical Science and Engineering 2015年第1期8卷 40-45页

作者： Annelieke C. Kruithof Matthijs Moerland Eleftheria A. Anastasopoulou Pieter-Jan de Kam Marieke L. de Kam Jacobus Burggraaf Department of Vascular Medicine Centre for Human Drug Research Leiden The Netherlands Department of Clinical Pharmacology Merck Sharp & Dohme Corp. Rahway USA Department of Pharmacometrics Centre for Human Drug Research Leiden The Netherlands

Given the broad application of aspirin as antiplatelet drug, availability of standardized methodology to assess potential interaction with any co-medication on platelet aggregation is desired. We characterized the effect of aspirin (ASA) therapy on collagen-induced platelet aggregation in whole blood to define such methodology. Collagen-induced platelet whole blood aggregation was assessed in 6 healthy male volunteers on 2 occasions (Day 1, Day 7) using the Chronolog aggregometer. From Day 2 up to Day 7, subjects received a daily oral dose of 75 mg ASA. The relationship between collagen dose and platelet aggregation response was assessed. On Day 1, maximal aggregation was observed at 1 μg/mL collagen (15.3 ± 4.6 Ω) and higher. Reproducible results were obtained without any indication of intra-subject fluctuations. ASA treatment decreased maximal aggregation by 80% and 38% at 0.5 and 2.0 μg/mL collagen, respectively. Power calculations were performed based on the observed intra-subject variability and demonstrated minimal sample sizes of 9 - 11 subjects for future cross-over ASA-drug interaction studies exploring effects on platelet aggregation, which demonstrates that the proposed collagen-induced ex vivo whole blood platelet aggregation is a feasible methodology to evaluate ASA-drug interactions in healthy volunteers.

关键词： Platelet Aggregation Impedance Aggregometry Whole Blood Collagen Aspirin Interaction

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NOTUM inhibition increases endocortical bone formation and bone strength

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Bone Research 2019年第1期7卷 54-65页

作者： Robert Brommage Jeff Liu Peter Voge Faika Mseeh Andrea Y.Thompson David G.Potter Melanie K.Shadoan Gwenn M.Hansen Sabrina Jeter-Jones Jie Cui Dawn Bright Jennifer P.Bardenhagen Deon D.Doree Sofia Moverare-Skrtic Karin H.Nilsson Petra Henning Ulf H.Lerner Claes Ohlsson Arthur T.Sands James E.Tarver David R.Powell Brian Zambrowicz Qingyun Liu Lexicon Pharmaceuticals The WoodlandsTXUSA Wntrix HoustonTXUSA PRA Health Sciences RaleighNCUSA University of Pennsylvania PhiladelphiaPAUSA Regeneron Pharmaceuticals TarrytownNYUSA University of Texas HoustonTXUSA Centre for Bone and Arthritis Research Institute of MedicineThe Sahlgrenska Academy at University of GothenburgGothenburgSweden Centre for Bone and Arthritis Research University of GothenburgGothenburgSweden Biogen CambridgeMAUSA St.Jude Children’s Research Hospital MemphisTNUSA MD Anderson Cancer Center HoustonTXUSA Bethyl Laboratories MontgomeryTXUSA Merck RahwayNJUSA Nurix San FranciscoCAUSA

The disability,mortality and costs caused by non-vertebral osteoporotic fractures are *** osteoporosis therapies are highly effective at reducing vertebral but not non-vertebral *** bone is a major determinant of non-vertebral bone *** identify novel osteoporosis drug targets,we phenotyped cortical bone of 3 366 viable mouse strains with global knockouts of druggable *** bone thickness was substantially elevated in Notum?/?*** is a secreted WNT lipase and we observed high NOTUM expression in cortical bone and osteoblasts but not *** orally active small molecules and a neutralizing antibody inhibiting NOTUM lipase activity were *** increased cortical bone thickness and strength at multiple skeletal sites in both gonadal intact and ovariectomized rodents by stimulating endocortical bone ***,inhibition of NOTUM activity is a potential novel anabolic therapy for strengthening cortical bone and preventing non-vertebral fractures.

关键词： disability osteoporosis fractures

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发情周期生理

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草食家畜 1984年第S1期 99-113页

作者： William Hansel,Edward M.Convey,董伟 Dept.of Physiol. NY State College of Vet.Med. Cornell Univ. Aerck Sharp and Dohme Research.Laboratories rahway NJ.

文中对牛、羊、猪的卵泡生长和排卵,丘脑下部—垂体—卵巢的互作,黄体功能和发情周期的调节等问题的现有观点和新的提法进行了综述。在整个发情周期中,卵泡持续不断地生长、退化和被其他的大卵泡代替。在这个过程中,卵巢内部因素似乎起... 详细信息

文中对牛、羊、猪的卵泡生长和排卵,丘脑下部—垂体—卵巢的互作,黄体功能和发情周期的调节等问题的现有观点和新的提法进行了综述。在整个发情周期中,卵泡持续不断地生长、退化和被其他的大卵泡代替。在这个过程中,卵巢内部因素似乎起重要作用。排卵前卵泡内雌二醇的浓度在LH的排卵前高峰到来之前一直增长,然后急速下降。人们提出了一个所谓控制卵泡类固醇合成的二细胞—二促性腺激素的模式,这个概念还提出,卵泡的雄激素是通过A5通路合成的,细胞内高浓度的雌二醇在LH峰出现之前抑制着孕酮的生产。有人认为卵巢组织能生产非类固醇的FSH和丘脑下部激素的抑制剂。我们的现代概念大概只是对黄体退化时发生的情况的部分解释。有例证说明前列环素（prostacyclin）和PGE2在黄体生长期分别对母牛和绵羊具有促黄体的作用。最近的一些研究认为催产素对牛、羊的黄体退化可能具有生理功能。磷酯的甲基化,看来对LH刺激黄体细胞腺甙酸环化酶（adeny-late cyclase）和后来孕酮生产的机制,是一个重要的调节步骤。促性腺激素的分泌有明显的间歇,依周期阶段和生殖状态而变化。引用的文献与下述观点是相吻合的,即在GnRH的脉冲式释放的连续影响和雌激素的控制下,LH的脉冲式释放量也依次逐渐增多,从而产生了排卵前的LH峰。已

关键词：卵泡闭锁 FSH LH 卵巢疾病孕酮孕激素雌二醇雌激素发情周期促性腺激素激素类药物卵巢性腺排卵前黄体细胞

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